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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 - 08800039101011

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.
BAN-55003b
In Commercial Distribution

  • 08800039101011 ()


  • Tendon/ligament bone anchor, bioabsorbable

Fixone Biocomposite Anchor - 08800039101004

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.
BAN-55002c
In Commercial Distribution

  • 08800039101004 ()


  • Tendon/ligament bone anchor, bioabsorbable

Fixone Biocomposite Anchor - 08800039100991

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.
BAN-47503b
In Commercial Distribution

  • 08800039100991 ()


  • Tendon/ligament bone anchor, bioabsorbable

Fixone Biocomposite Anchor - 08800039100984

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.
BAN-47502c
In Commercial Distribution

  • 08800039100984 ()


  • 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

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 Machined Driver - 08800039377997

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

  • 08800039377997 ()


  • Fixture/appliance dental drill bit, reusable

Magicore Machined Driver - 08800039377980

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

  • 08800039377980 ()


  • Fixture/appliance dental drill bit, reusable

Millennium - 00190776381547

Rush Style Aluminum Mallet, 1lb, 229mm OL
Avalign Technologies, Inc.
1-851M
In Commercial Distribution

  • 00190776381547 ()


  • Surgical mallet

Millennium - 00190776380656

Soft Impact Mallet, 4lbs, with easy grip handle
Avalign Technologies, Inc.
1-78374
In Commercial Distribution

  • 00190776380656 ()


  • Surgical mallet

Millennium - 00190776377229

BioRCl Screw Driver
Avalign Technologies, Inc.
72-137208656
In Commercial Distribution

  • 00190776377229 ()


  • Arthroscopic surgical procedure kit, non-medicated, reusable

Millennium - 00190776376765

Screwdriver Handle
Avalign Technologies, Inc.
0-48373
In Commercial Distribution

  • 00190776376765 ()


  • Surgical screwdriver, reusable

Avalign - 00190776368340

Rizzuti Superior Rectus
Avalign Technologies, Inc.
VM91-5423
In Commercial Distribution

  • 00190776368340 ()


  • Orthopaedic implant driver

Dyna Locking Cannulated Screw - 08800037575791

No Description
CG MedTech Co.,Ltd.
TC6506
In Commercial Distribution

  • 08800037575791 ()


  • Orthopaedic implant driver

Dyna Locking Cannulated Screw - 08800037575784

No Description
CG MedTech Co.,Ltd.
TC6505
In Commercial Distribution

  • 08800037575784 ()


  • Orthopaedic implant driver

Dyna Locking Cannulated Screw - 08800037575722

No Description
CG MedTech Co.,Ltd.
TC5006
In Commercial Distribution

  • 08800037575722 ()


  • Orthopaedic implant driver

Dyna Locking Cannulated Screw - 08800037575715

No Description
CG MedTech Co.,Ltd.
TC5005
In Commercial Distribution

  • 08800037575715 ()


  • Orthopaedic implant driver

Dyna Locking Cannulated Screw - 08800037575654

No Description
CG MedTech Co.,Ltd.
TC4006
In Commercial Distribution

  • 08800037575654 ()


  • Orthopaedic implant driver

Dyna Locking Cannulated Screw - 08800037575647

No Description
CG MedTech Co.,Ltd.
TC4005
In Commercial Distribution

  • 08800037575647 ()


  • Orthopaedic implant driver

Benefix™ Interspinous Fixation System - 08800037575562

No Description
CG MedTech Co.,Ltd.
ISS2040
In Commercial Distribution

  • 08800037575562 ()


  • Orthopaedic implant driver

Velofix™ TLIF Cage - 08800037574619

No Description
CG MedTech Co.,Ltd.
TL0250
In Commercial Distribution

  • 08800037574619 ()


  • Orthopaedic implant driver

Velofix™ TLIF Cage - 08800037574572

No Description
CG MedTech Co.,Ltd.
TL0210
In Commercial Distribution

  • 08800037574572 ()


  • Orthopaedic implant driver

ANAX™ OCT SPINAL SYSTEM - 08800037574473

No Description
CG MedTech Co.,Ltd.
OSS0450
In Commercial Distribution

  • 08800037574473 ()


  • Surgical screwdriver, reusable

Velofix™ SA Cervical Cage - 08800037568601

No Description
CG MedTech Co.,Ltd.
TS0170
In Commercial Distribution

  • 08800037568601 ()


  • Orthopaedic implant driver

ANAX™ 5.5 SPINAL SYSTEM - 08800037568458

No Description
CG MedTech Co.,Ltd.
SFM0130
In Commercial Distribution

  • 08800037568458 ()


  • Orthopaedic implant driver

ANAX™ 5.5 SPINAL SYSTEM - 08800037568441

No Description
CG MedTech Co.,Ltd.
SFM0120
In Commercial Distribution

  • 08800037568441 ()


  • Orthopaedic implant driver

Velofix™ SA Cervical Cage - 08800037568410

No Description
CG MedTech Co.,Ltd.
TS0070
In Commercial Distribution

  • 08800037568410 ()


  • Orthopaedic implant driver

ANAX™ 5.5 SPINAL SYSTEM - 08800037567413

No Description
CG MedTech Co.,Ltd.
SFS1090
In Commercial Distribution

  • 08800037567413 ()


  • Surgical screwdriver, reusable

ANAX™ 5.5 SPINAL SYSTEM - 08800037567406

No Description
CG MedTech Co.,Ltd.
SFS1080
In Commercial Distribution

  • 08800037567406 ()


  • Surgical screwdriver, reusable

OMEGA XP - 00840606163286

OMEGA XP® AXIAL EXPANSION DRIVER
SPINAL ELEMENTS, INC.
11418-295
In Commercial Distribution

  • 00840606163286 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

OMEGA XP - 00840606163262

OMEGA XP® EXPANSION DRIVER
SPINAL ELEMENTS, INC.
11418-095
In Commercial Distribution

  • 00840606163262 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

OVERWATCH - 00840606157551

T20 Driver 12"
SPINAL ELEMENTS, INC.
T20-00-12-0
In Commercial Distribution

  • 00840606157551 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

OVERWATCH - 00840606157537

T20 Driver 11"
SPINAL ELEMENTS, INC.
T20-00-11-0
In Commercial Distribution

  • 00840606157537 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

OVERWATCH - 00840606157506

T20 Driver 9" Cannulated
SPINAL ELEMENTS, INC.
T20-00-09-C
In Commercial Distribution

  • 00840606157506 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

OVERWATCH - 00840606157483

T20 Driver 8" Cannulated
SPINAL ELEMENTS, INC.
T20-00-08-C
In Commercial Distribution

  • 00840606157483 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

OVERWATCH - 00840606157469

T20 Driver 7" Cannulated
SPINAL ELEMENTS, INC.
T20-00-07-C
In Commercial Distribution

  • 00840606157469 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

OVERWATCH - 00840606157445

T20 Driver 6" Cannulated
SPINAL ELEMENTS, INC.
T20-00-06-C
In Commercial Distribution

  • 00840606157445 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

OVERWATCH - 00840606157421

T20 Driver 5" Cannulated
SPINAL ELEMENTS, INC.
T20-00-05-C
In Commercial Distribution

  • 00840606157421 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

CERES - 00840606157278

CERES SCREW DRIVER SPIN SLEEVE
SPINAL ELEMENTS, INC.
12-30-1009
In Commercial Distribution

  • 00840606157278 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

MOSAIC - 00840606155557

BREAKAWAY DRIVER
SPINAL ELEMENTS, INC.
50115-000
In Commercial Distribution

  • 00840606155557 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

OVERWATCH - 00840606154666

OVERWATCH® SPIN DRIVER – LOCKING KNOB
SPINAL ELEMENTS, INC.
SP-0564-3
In Commercial Distribution

  • 00840606154666 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

MERCURY - 00840606154215

Mercury® N Driver Cannulated
SPINAL ELEMENTS, INC.
62150-050-01C
In Commercial Distribution

  • 00840606154215 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

OVERWATCH - 00840606154192

Overwatch® Iliac N Driver
SPINAL ELEMENTS, INC.
108-457-01
In Commercial Distribution

  • 00840606154192 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

TALON - 00840606151351

3.5MM TALON SCREW DRIVER, CANNULATED
SPINAL ELEMENTS
CTL1116
In Commercial Distribution

  • 00840606151351 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

Velofix™ SA Cervical Cage - 08800037551160

No Description
CG MedTech Co.,Ltd.
TSS1010
In Commercial Distribution

  • 08800037551160 ()


  • Surgical screwdriver, reusable

PERFIX™ SPINAL SYSTEM - 08800037551153

No Description
CG MedTech Co.,Ltd.
ST9019R
In Commercial Distribution

  • 08800037551153 ()


  • Surgical screwdriver, reusable

PERFIX™ SPINAL SYSTEM - 08800037551146

No Description
CG MedTech Co.,Ltd.
ST9018R
In Commercial Distribution

  • 08800037551146 ()


  • Surgical screwdriver, reusable

OPTIMA™ Spinal System - 08800037551139

No Description
CG MedTech Co.,Ltd.
SP0026
In Commercial Distribution

  • 08800037551139 ()


  • Surgical screwdriver, reusable

Perfix™ Spinal System - 08800037551108

No Description
CG MedTech Co.,Ltd.
SN0053
In Commercial Distribution

  • 08800037551108 ()


  • Surgical screwdriver, reusable

Global Spinal Fixation System™ - 08800037551078

No Description
CG MedTech Co.,Ltd.
SG0032
In Commercial Distribution

  • 08800037551078 ()


  • Surgical screwdriver, reusable
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