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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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Large handle, cannulated, quick coupling
Bioretec Oy
B-ISC-9013
In Commercial Distribution

  • E302BISC90139 ()
B-ISC-9013

  • Surgical screwdriver, reusable
Direct driver, for 4.0/4.5 mm cannulated screws
Bioretec Oy
B-ISC-4502
In Commercial Distribution

  • E302BISC45029 ()
B-ISC-4502

  • Surgical screwdriver, reusable
Direct driver, for 3.5 mm cannulated screws
Bioretec Oy
B-ISC-3502
In Commercial Distribution

  • E302BISC35029 ()
B-ISC-3502

  • Surgical screwdriver, reusable
HEX shaft, for 4.5mm screws
Bioretec Oy
B-IS-9033
In Commercial Distribution

  • E302BIS90339 ()
B-IS-9033

  • Surgical screwdriver, reusable
HEX shaft, for 2.0/2.7/3.5 mm screws
Bioretec Oy
B-IS-9032
In Commercial Distribution

  • E302BIS90329 ()
B-IS-9032

  • Surgical screwdriver, reusable
Torx shaft for 4/5/6 mm interference screw with quick coupling
Bioretec Oy
B-II-9032
In Commercial Distribution

  • E302BII90329 ()
B-II-9032

  • Surgical screwdriver, reusable
Torx driver, for 7/8/9/10 mm interference screws
Bioretec Oy
B-II-9031
In Commercial Distribution

  • E302BII90319 ()
B-II-9031

  • Surgical screwdriver, reusable
Driver, Solid 5.0mm Hex
ORTHOPEDIATRICS CORP.
01-9200-0050
In Commercial Distribution

  • 00840194465281 ()
01-9200-0050

  • Surgical screwdriver, reusable
Driver, Cannulated 4.5mm Hex
ORTHOPEDIATRICS CORP.
01-9200-0145
In Commercial Distribution

  • 00840194465274 ()
01-9200-0145

  • Surgical screwdriver, reusable
Driver, Cannulated 4.0mm Hex
ORTHOPEDIATRICS CORP.
01-9200-0140
In Commercial Distribution

  • 00840194465250 ()
01-9200-0140

  • Surgical screwdriver, reusable
Driver, Cannulated 3.5mm Hex
ORTHOPEDIATRICS CORP.
01-9200-0135
In Commercial Distribution

  • 00840194465236 ()
01-9200-0135

  • Surgical screwdriver, reusable
Driver, Solid 3.0mm Hex
ORTHOPEDIATRICS CORP.
01-9200-0030
In Commercial Distribution

  • 00840194465205 ()
01-9200-0030

  • Surgical screwdriver, reusable
Driver, Cannulated 2.5mm Hex
ORTHOPEDIATRICS CORP.
01-9200-0125
In Commercial Distribution

  • 00840194465199 ()
01-9200-0125

  • Surgical screwdriver, reusable
Driver, Solid T20
ORTHOPEDIATRICS CORP.
01-9200-0020
In Commercial Distribution

  • 00840194465168 ()
01-9200-0020

  • Surgical screwdriver, reusable
Driver, Solid T15
ORTHOPEDIATRICS CORP.
01-9200-0015
In Commercial Distribution

  • 00840194465144 ()
01-9200-0015

  • Surgical screwdriver, reusable
5.5/6.0 Cannulated Reduction Pedicle Screw Driver Navigation
ORTHOPEDIATRICS CORP.
01-1800-6043
In Commercial Distribution

  • 00840194462785 ()
01-1800-6043

  • Surgical screwdriver, reusable
5.5/6.0 Reduction Pedicle Screw Driver Navigation
ORTHOPEDIATRICS CORP.
01-1800-6041
In Commercial Distribution

  • 00840194462761 ()
01-1800-6041

  • Surgical screwdriver, reusable
5.5/6.0 Pedicle Screw Driver Navigation
ORTHOPEDIATRICS CORP.
01-1800-6040
In Commercial Distribution

  • 00840194462754 ()
01-1800-6040

  • Surgical screwdriver, reusable
5.5/6.0 Closed Cannulated Pedicle Screw Driver, Square
ORTHOPEDIATRICS CORP.
01-1301-6041
In Commercial Distribution

  • 00840194445825 ()
01-1301-6041

  • Surgical screwdriver, reusable
4.5/5.0 Power Pedicle Reduction Screw Driver, 140MM
ORTHOPEDIATRICS CORP.
01-1600-9011
In Commercial Distribution

  • 00840194444934 ()
01-1600-9011

  • Surgical screwdriver, reusable
5.5/6.0 Power CANNULATED Pedicle Reduction Screw Driver, 140MM
ORTHOPEDIATRICS CORP.
01-1301-9011
In Commercial Distribution

  • 00840194444910 ()
01-1301-9011

  • Surgical screwdriver, reusable
5.5/6.0 Power Reduction Screw Driver, 140MM
ORTHOPEDIATRICS CORP.
01-1300-9011
In Commercial Distribution

  • 00840194444897 ()
01-1300-9011

  • Surgical screwdriver, reusable
Screwdriver, 4mm Hex, Short
ORTHOPEDIATRICS CORP.
01-1510-0025
In Commercial Distribution

  • 00840194429009 ()
01-1510-0025

  • Surgical screwdriver, reusable
Tapered Screw Driver, 4.0 Hex, Short, ZH QC
ORTHOPEDIATRICS CORP.
01-1510-0043
In Commercial Distribution

  • 00840194428675 ()
01-1510-0043

  • Surgical screwdriver, reusable
T15 Screw Driver - Retaining
ORTHOPEDIATRICS CORP.
01-1600-4003
In Commercial Distribution

  • 00840194428538 ()
01-1600-4003

  • Surgical screwdriver, reusable
No Description
Navinetics, Inc.
NN0110
In Commercial Distribution

  • 10850023620245 ()


  • Neurological stereotactic surgery system
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
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
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
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
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