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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Fixone Biocomposite Anchor - 08800039100809

The Fixone Biocomposite Anchor is intended for reattaching soft tissue to bone with sutures. The anchor ismanufactured from biodegradable materials (PLGA copolymer and beta-TCP). A nonabsorbable UHMWPE suture is inserted into the anchor. The anchor is implanted using a provided driver. B,N,BN type(Knotted suture anchors) are ‘screw-in’ anchors used alone or in combination with Kc,KcN type(Knotless suture anchors) for soft-tissue repair. Kc,KcN type(Knotless suture anchor) are used for a soft-tissue repair in combination with the B,N,BN type. SL type ‘push-in’ anchors that are ideal for soft-tissue repair in narrow or deep areas. S type are ‘push-in’ anchors that are ideal for soft-tissue repair in the foot, ankle, hand and wrist The Fixone Biocomposite Anchor consists of cannulated anchors with an eyelet. They are pre-loaded on an insertion device. The Fixone Biocomposite Anchor is intended to provide secure reattachment of the soft tissue to bone. Devices are provided sterile. Single use only.
AJU PHARM. CO., LTD.
KAB-55001da
In Commercial Distribution

  • 08800039100809 ()


  • Tendon/ligament bone anchor, bioabsorbable

Fixone Biocomposite Anchor - 08800039100786

The Fixone Biocomposite Anchor is intended for reattaching soft tissue to bone with sutures. The anchor ismanufactured from biodegradable materials (PLGA copolymer and beta-TCP). A nonabsorbable UHMWPE suture is inserted into the anchor. The anchor is implanted using a provided driver. B,N,BN type(Knotted suture anchors) are ‘screw-in’ anchors used alone or in combination with Kc,KcN type(Knotless suture anchors) for soft-tissue repair. Kc,KcN type(Knotless suture anchor) are used for a soft-tissue repair in combination with the B,N,BN type. SL type ‘push-in’ anchors that are ideal for soft-tissue repair in narrow or deep areas. S type are ‘push-in’ anchors that are ideal for soft-tissue repair in the foot, ankle, hand and wrist The Fixone Biocomposite Anchor consists of cannulated anchors with an eyelet. They are pre-loaded on an insertion device. The Fixone Biocomposite Anchor is intended to provide secure reattachment of the soft tissue to bone. Devices are provided sterile. Single use only.
AJU PHARM. CO., LTD.
KAB-47501ca
In Commercial Distribution

  • 08800039100786 ()


  • Tendon/ligament bone anchor, bioabsorbable

Fixone Hybrid Anchor - 08800039100601

The Fixone Hybrid Knotless Anchor is intended for reattaching soft tissue to bone with sutures. The anchor is manufactured from biodegradable materials (PLGA copolymer and beta-TCP) and nonabsorbable PEEK tip. A nonabsorbable suture manufactured from cobraided UHMWPE only or UHMWPE and PET fibers is inserted into the anchor. The anchor is implanted using a provided driver.
AJU PHARM. CO., LTD.
KAP-55001ca
In Commercial Distribution

  • 08800039100601 ()


  • Tendon/ligament bone anchor, bioabsorbable

Fixone Hybrid Anchor - 08800039100571

The Fixone Hybrid Knotless Anchor is intended for reattaching soft tissue to bone with sutures. The anchor is manufactured from biodegradable materials (PLGA copolymer and beta-TCP) and nonabsorbable PEEK tip. A nonabsorbable suture manufactured from cobraided UHMWPE only or UHMWPE and PET fibers is inserted into the anchor. The anchor is implanted using a provided driver.
AJU PHARM. CO., LTD.
KAP-47501ca
In Commercial Distribution

  • 08800039100571 ()


  • Tendon/ligament bone anchor, bioabsorbable

Fixone Biocomposite Anchor - 08800039100380

The Fixone Biocomposite Anchor is intended for reattaching soft tissue to bone with sutures. The anchor ismanufactured from biodegradable materials (PLGA copolymer and beta-TCP). A nonabsorbable UHMWPE suture is inserted into the anchor. The anchor is implanted using a provided driver. B,N,BN type(Knotted suture anchors) are ‘screw-in’ anchors used alone or in combination with Kc,KcN type(Knotless suture anchors) for soft-tissue repair. Kc,KcN type(Knotless suture anchor) are used for a soft-tissue repair in combination with the B,N,BN type. SL type ‘push-in’ anchors that are ideal for soft-tissue repair in narrow or deep areas. S type are ‘push-in’ anchors that are ideal for soft-tissue repair in the foot, ankle, hand and wrist The Fixone Biocomposite Anchor consists of cannulated anchors with an eyelet. They are pre-loaded on an insertion device. The Fixone Biocomposite Anchor is intended to provide secure reattachment of the soft tissue to bone. Devices are provided sterile. Single use only.
AJU PHARM. CO., LTD.
NAB-47502d
In Commercial Distribution

  • 08800039100380 ()


  • Tendon/ligament bone anchor, bioabsorbable

Fixone Biocomposite Anchor - 08800039100335

The Fixone Biocomposite Anchor is intended for reattaching soft tissue to bone with sutures. The anchor ismanufactured from biodegradable materials (PLGA copolymer and beta-TCP). A nonabsorbable UHMWPE suture is inserted into the anchor. The anchor is implanted using a provided driver. B,N,BN type(Knotted suture anchors) are ‘screw-in’ anchors used alone or in combination with Kc,KcN type(Knotless suture anchors) for soft-tissue repair. Kc,KcN type(Knotless suture anchor) are used for a soft-tissue repair in combination with the B,N,BN type. SL type ‘push-in’ anchors that are ideal for soft-tissue repair in narrow or deep areas. S type are ‘push-in’ anchors that are ideal for soft-tissue repair in the foot, ankle, hand and wrist The Fixone Biocomposite Anchor consists of cannulated anchors with an eyelet. They are pre-loaded on an insertion device. The Fixone Biocomposite Anchor is intended to provide secure reattachment of the soft tissue to bone. Devices are provided sterile. Single use only.
AJU PHARM. CO., LTD.
SAL-30002i
In Commercial Distribution

  • 08800039100335 ()


  • Tendon/ligament bone anchor, bioabsorbable

Fixone Biocomposite Anchor - 08800039100083

The Fixone Biocomposite Anchor is intended for reattaching soft tissue to bone with sutures. The anchor ismanufactured from biodegradable materials (PLGA copolymer and beta-TCP). A nonabsorbable UHMWPE suture is inserted into the anchor. The anchor is implanted using a provided driver. B,N,BN type(Knotted suture anchors) are ‘screw-in’ anchors used alone or in combination with Kc,KcN type(Knotless suture anchors) for soft-tissue repair. Kc,KcN type(Knotless suture anchor) are used for a soft-tissue repair in combination with the B,N,BN type. SL type ‘push-in’ anchors that are ideal for soft-tissue repair in narrow or deep areas. S type are ‘push-in’ anchors that are ideal for soft-tissue repair in the foot, ankle, hand and wrist The Fixone Biocomposite Anchor consists of cannulated anchors with an eyelet. They are pre-loaded on an insertion device. The Fixone Biocomposite Anchor is intended to provide secure reattachment of the soft tissue to bone. Devices are provided sterile. Single use only.
AJU PHARM. CO., LTD.
KAB-55001ca
In Commercial Distribution

  • 08800039100083 ()


  • Tendon/ligament bone anchor, bioabsorbable

Fixone Biocomposite Anchor - 08800039100045

The Fixone Biocomposite Anchor is intended for reattaching soft tissue to bone with sutures. The anchor ismanufactured from biodegradable materials (PLGA copolymer and beta-TCP). A nonabsorbable UHMWPE suture is inserted into the anchor. The anchor is implanted using a provided driver. B,N,BN type(Knotted suture anchors) are ‘screw-in’ anchors used alone or in combination with Kc,KcN type(Knotless suture anchors) for soft-tissue repair. Kc,KcN type(Knotless suture anchor) are used for a soft-tissue repair in combination with the B,N,BN type. SL type ‘push-in’ anchors that are ideal for soft-tissue repair in narrow or deep areas. S type are ‘push-in’ anchors that are ideal for soft-tissue repair in the foot, ankle, hand and wrist The Fixone Biocomposite Anchor consists of cannulated anchors with an eyelet. They are pre-loaded on an insertion device. The Fixone Biocomposite Anchor is intended to provide secure reattachment of the soft tissue to bone. Devices are provided sterile. Single use only.
AJU PHARM. CO., LTD.
BAB-55003ch
In Commercial Distribution

  • 08800039100045 ()


  • Tendon/ligament bone anchor, bioabsorbable

Fixone Biocomposite Anchor - 08800039100038

The Fixone Biocomposite Anchor is intended for reattaching soft tissue to bone with sutures. The anchor ismanufactured from biodegradable materials (PLGA copolymer and beta-TCP). A nonabsorbable UHMWPE suture is inserted into the anchor. The anchor is implanted using a provided driver. B,N,BN type(Knotted suture anchors) are ‘screw-in’ anchors used alone or in combination with Kc,KcN type(Knotless suture anchors) for soft-tissue repair. Kc,KcN type(Knotless suture anchor) are used for a soft-tissue repair in combination with the B,N,BN type. SL type ‘push-in’ anchors that are ideal for soft-tissue repair in narrow or deep areas. S type are ‘push-in’ anchors that are ideal for soft-tissue repair in the foot, ankle, hand and wrist The Fixone Biocomposite Anchor consists of cannulated anchors with an eyelet. They are pre-loaded on an insertion device. The Fixone Biocomposite Anchor is intended to provide secure reattachment of the soft tissue to bone. Devices are provided sterile. Single use only.
AJU PHARM. CO., LTD.
BAB-55002dh
In Commercial Distribution

  • 08800039100038 ()


  • Tendon/ligament bone anchor, bioabsorbable

Fixone Biocomposite Anchor - 08800039100021

The Fixone Biocomposite Anchor is intended for reattaching soft tissue to bone with sutures. The anchor ismanufactured from biodegradable materials (PLGA copolymer and beta-TCP). A nonabsorbable UHMWPE suture is inserted into the anchor. The anchor is implanted using a provided driver. B,N,BN type(Knotted suture anchors) are ‘screw-in’ anchors used alone or in combination with Kc,KcN type(Knotless suture anchors) for soft-tissue repair. Kc,KcN type(Knotless suture anchor) are used for a soft-tissue repair in combination with the B,N,BN type. SL type ‘push-in’ anchors that are ideal for soft-tissue repair in narrow or deep areas. S type are ‘push-in’ anchors that are ideal for soft-tissue repair in the foot, ankle, hand and wrist The Fixone Biocomposite Anchor consists of cannulated anchors with an eyelet. They are pre-loaded on an insertion device. The Fixone Biocomposite Anchor is intended to provide secure reattachment of the soft tissue to bone. Devices are provided sterile. Single use only.
AJU PHARM. CO., LTD.
BAB-45003ch
In Commercial Distribution

  • 08800039100021 ()


  • Tendon/ligament bone anchor, bioabsorbable

MEDINAUT MAX - 08800038053052

MEDINAUT MAX Wire-Pin Driver Attachment
IMEDICOM CO., LTD.
BMA-W10
Not in Commercial Distribution

  • 08800038053052 ()


  • Multi-purpose surgical power tool system, rechargeable battery-powered

Magicore Ratchet Driver - 08800039308649

No Description
InnoBioSurg Co.,Ltd(IBS implant Co.,Ltd)
MRMDL
In Commercial Distribution

  • 08800039308649 ()


  • Fixture/appliance dental drill bit, reusable

MILLENNIUM - 00190776343279

Hexagonal Screwdriver,
Avalign Technologies, Inc.
0-48349
In Commercial Distribution

  • 00190776343279 ()


  • Surgical screwdriver, reusable

MILLENNIUM - 00190776343231

Screwdriver
Avalign Technologies, Inc.
0-48352
In Commercial Distribution

  • 00190776343231 ()


  • Surgical screwdriver, reusable

MILLENNIUM - 00190776343224

Screwdriver
Avalign Technologies, Inc.
0-48355
In Commercial Distribution

  • 00190776343224 ()


  • Surgical screwdriver, reusable

MILLENNIUM - 00190776339500

Toronto Bone Mallet 24 oz
Avalign Technologies, Inc.
25-771102
In Commercial Distribution

  • 00190776339500 ()


  • Surgical mallet

Millennium - 00190776339494

Toronto Bone Mallet Metal, 32oz 2 1/4" end and 1 7/8" end OL 203.2mm (8")
Avalign Technologies, Inc.
85-651
In Commercial Distribution

  • 00190776339494 ()


  • Surgical mallet

MILLENNIUM - 00190776339487

Orthopedic Mallet 2lbs
Avalign Technologies, Inc.
0-49762
In Commercial Distribution

  • 00190776339487 ()


  • Surgical mallet

MILLENNIUM - 00190776339463

Phenolic Handle Mallet, 1lb
Avalign Technologies, Inc.
0-46688
In Commercial Distribution

  • 00190776339463 ()


  • Surgical mallet

MILLENNIUM - 00190776339456

Hammer, Phenolic Handle
Avalign Technologies, Inc.
85-597644
In Commercial Distribution

  • 00190776339456 ()


  • Surgical mallet

MILLENNIUM - 00190776339449

Mallet 1lb
Avalign Technologies, Inc.
0-46690
In Commercial Distribution

  • 00190776339449 ()


  • Surgical mallet

MILLENNIUM - 00190776339432

Bone Mallet 2 lbs
Avalign Technologies, Inc.
0-46667
In Commercial Distribution

  • 00190776339432 ()


  • Surgical mallet

MILLENNIUM - 00190776339425

Bone Mallet 1lb
Avalign Technologies, Inc.
0-46666
In Commercial Distribution

  • 00190776339425 ()


  • Surgical mallet

MILLENNIUM - 00190776339388

Ombredanne Mallet 18.3 oz
Avalign Technologies, Inc.
11-FL066R
In Commercial Distribution

  • 00190776339388 ()


  • Surgical mallet

MILLENNIUM - 00190776339371

Bergman Hibbs Mallet
Avalign Technologies, Inc.
12-882520
In Commercial Distribution

  • 00190776339371 ()


  • Surgical mallet

MILLENNIUM - 00190776339364

Bergman Mallet, 10.5 oz
Avalign Technologies, Inc.
85-58000576
In Commercial Distribution

  • 00190776339364 ()


  • Surgical mallet

MILLENNIUM - 00190776339357

Linen Phenolic Mallet
Avalign Technologies, Inc.
85-58000570
In Commercial Distribution

  • 00190776339357 ()


  • Surgical mallet

MILLENNIUM - 00190776339333

Mallet, 12 oz, 8 oz head,
Avalign Technologies, Inc.
0-46687
In Commercial Distribution

  • 00190776339333 ()


  • Surgical mallet

MILLENNIUM - 00190776339319

Hajek Bone Mallet
Avalign Technologies, Inc.
85-597870
In Commercial Distribution

  • 00190776339319 ()


  • Surgical mallet

TensionTac Insertion Tool - 10854629006878

TensionTac Insertion Tool
DUNAMIS MEDICAL, LLC
DFX0044T
In Commercial Distribution

  • 10854629006878 ()
DFX0044T

  • Surgical screwdriver, reusable

CONMED - 10845854028650

2-TRIGGER 4 MM PIN DRIVER ATTACHMENT
Conmed Corporation
PRO6232-4
In Commercial Distribution

  • 10845854028650 ()
  • 20845854028657 ()
PRO6232-4

  • Pin-driving power tool attachment

BIOSCREW - 10845854026762

BIOSCREW FLEXIBLE DRIVER
Conmed Corporation
C8616
Not in Commercial Distribution

  • 20845854026769 ()
  • 10845854026762 ()
C8616

  • Orthopaedic implantation sleeve, reusable

REVO - 10845854026717

Thin Shaft Revo Driver
Conmed Corporation
C6102B
In Commercial Distribution

  • 10845854026717 ()
  • 20845854026714 ()
C6102B

  • Orthopaedic implant driver

CONMED - 10845854025383

CANNULATED SCREW DRIVER, 3.5 MM
Conmed Corporation
8608
In Commercial Distribution

  • 20845854025380 ()
  • 10845854025383 ()

  • Length: 3.5 Millimeter
8608

  • Orthopaedic implant driver

ULTRAFIX - 10845854024195

ULTRAFIX ARTHROSCOPIC INSERTER
Conmed Corporation
10121
In Commercial Distribution

  • 20845854024192 ()
  • 10845854024195 ()
10121

  • Orthopaedic implant driver

ULTRAPOWER - 10845854023990

ULTRAPOWER FOOT CONTROL
Conmed Corporation
00702004500
In Commercial Distribution

  • 20845854023997 ()
  • 10845854023990 ()
7020-45

  • Foot-switch, pneumatic

MICRO 100 - 10845854022993

MICRO 100 FOOT CONTROL
Conmed Corporation
1207-204
Not in Commercial Distribution

  • 30845854022997 ()
  • 10845854022993 ()
1207-204

  • Foot-switch, pneumatic

CONMED - 10845854018934

1.8-4 MM PIN DRIVER
Conmed Corporation
PRO6240
In Commercial Distribution

  • 10845854018934 ()
  • 20845854018931 ()
PRO6240

  • Pin-driving power tool attachment

PowerPro - 10845854018859

PowerPro Small 2-Trigger Wire Driver
Conmed Corporation
PRO6228
In Commercial Distribution

  • 10845854018859 ()
  • 20845854018856 ()
PRO6228

  • Pin-driving power tool attachment

SENTINEL - 10845854018286

SENTINEL CANNULATED DRILL BIT, 8 X 229 MM (9")
Conmed Corporation
S8580
In Commercial Distribution

  • 20845854018283 ()
  • 10845854018286 ()
  • 00845854018289 ()
S8580

  • Cannulated surgical drill bit, single-use

BIOSCREW - 10845854016664

BIOSCREW UNIVERSAL TRI-LOBE DRIVER
Conmed Corporation
C8715
In Commercial Distribution

  • 20845854016661 ()
  • 10845854016664 ()
C8715

  • Orthopaedic implant driver

PowerPro - 10845854013090

PPE II, PPP SINGLE TRIGGER WIRE DRIVER ATTACHMENT
Conmed Corporation
PRO6128
In Commercial Distribution

  • 20845854013097 ()
  • 10845854013090 ()
PRO6128

  • Pin-driving power tool attachment

CONMED - 10845854012864

SINGLE TRIGGER 4 MM PIN DRIVER ATTACHMENT
Conmed Corporation
PRO6132-4
In Commercial Distribution

  • 10845854012864 ()
  • 20845854012861 ()
PRO6132-4

  • Pin-driving power tool attachment

SENTINEL - 10845854012642

SENTINEL CANNULATED DRILL BIT, 7 X 229 MM (9")
Conmed Corporation
S8570
In Commercial Distribution

  • 20845854012649 ()
  • 10845854012642 ()
  • 00845854012645 ()
S8570

  • Cannulated surgical drill bit, single-use

SENTINEL - 10845854012635

SENTINEL CANNULATED DRILL BIT, 6.5 X 229 MM (9")
Conmed Corporation
S8565
In Commercial Distribution

  • 20845854012632 ()
  • 10845854012635 ()
  • 00845854012638 ()
S8565

  • Cannulated surgical drill bit, single-use

MAXI-DRIVER - 10845854010952

MAXI - DRIVER BLADE, RECIPROCATING, FINE 1.22 X 12.3 X 65.3MM
Conmed Corporation
P514
Not in Commercial Distribution

  • 10845854010952 ()

  • Height: 1.22 Millimeter
  • Width: 12.3 Millimeter
  • Length: 65.3 Millimeter
P514

  • Surgical saw blade, reciprocating, single-use

MAXI-DRIVER - 10845854009857

MAXI - DRIVER BLADE, OSCILLATING, FINE, 1.02 X 59.8 X 14.7 MM
Conmed Corporation
L129
In Commercial Distribution

  • 10845854009857 ()
L129

  • Surgical saw blade, oscillating, single-use

MAXI-DRIVER - 10845854009093

MAXI - DRIVER BLADE, OSCILLATING, COARSE, 1.63 X 60.8 X 29.6 MM
Conmed Corporation
L122
In Commercial Distribution

  • 10845854009093 ()
L122

  • Surgical saw blade, oscillating, single-use

MILLENNIUM - 00190776324285

Mallet Gerzog
Avalign Technologies, Inc.
85-46661
In Commercial Distribution

  • 00190776324285 ()


  • Surgical mallet

MILLENNIUM - 00190776324278

Copper Mallet small
Avalign Technologies, Inc.
2-1780
In Commercial Distribution

  • 00190776324278 ()


  • Surgical mallet
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