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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Internal Capture Release Driver
ORTHOPEDIATRICS CORP.
01-1510-0029
In Commercial Distribution

  • 00840194429047 ()
01-1510-0029

  • Surgical screwdriver, reusable
Internal Thread Capture, Long
ORTHOPEDIATRICS CORP.
01-1510-0028
In Commercial Distribution

  • 00840194429030 ()
01-1510-0028

  • Surgical screwdriver, reusable
Internal Thread Capture, Short
ORTHOPEDIATRICS CORP.
01-1510-0027
In Commercial Distribution

  • 00840194429023 ()
01-1510-0027

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

  • 00840194429009 ()
01-1510-0025

  • Surgical screwdriver, reusable
RFS Cannulated Direct driver 4.5
Bioretec Oy
RFS-CDDR45
Not in Commercial Distribution

  • E302RFSCDDR459 ()
RFS-CDDR45

  • Surgical screwdriver, reusable
RFS Cannulated Direct driver 3.5
Bioretec Oy
RFS-CDDR35
Not in Commercial Distribution

  • E302RFSCDDR359 ()
RFS-CDDR35

  • Surgical screwdriver, reusable
TorqLoc Large handle, cannulated, quick coupling
Bioretec Oy
OP-ISC-9013
Not in Commercial Distribution

  • E302OPISC90139 ()
OP-ISC-9013

  • Surgical screwdriver, reusable
TorqLoc Torx driver for 7/8/9/10 mm interference screw
Bioretec Oy
OP-II-9031
Not in Commercial Distribution

  • E302OPII90319 ()
OP-II-9031

  • Surgical screwdriver, reusable
Large handle, cannulated, quick coupling
Bioretec Oy
B-ISC-9013
In Commercial Distribution

  • E302BISC90139 ()
B-ISC-9013

  • 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
4.5/5.0 Pedicle Screw Driver, Navigation
ORTHOPEDIATRICS CORP.
01-1800-6044
In Commercial Distribution

  • 00840194466882 ()
01-1800-6044

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

  • 00840194465274 ()
01-9200-0145

  • Surgical screwdriver, reusable
Driver, Solid 4.0mm Hex
ORTHOPEDIATRICS CORP.
01-9200-0040
In Commercial Distribution

  • 00840194465243 ()
01-9200-0040

  • Surgical screwdriver, reusable
Driver, Solid 3.5mm Hex
ORTHOPEDIATRICS CORP.
01-9200-0035
In Commercial Distribution

  • 00840194465229 ()
01-9200-0035

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

  • 00840194465205 ()
01-9200-0030

  • 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
Ball Hex Driver, ZH QC
ORTHOPEDIATRICS CORP.
01-1510-0045
In Commercial Distribution

  • 00840194446099 ()
01-1510-0045

  • Surgical screwdriver, reusable
Tapered Screw Driver, 4.0 Hex, Long, ZH QC
ORTHOPEDIATRICS CORP.
01-1510-0044
In Commercial Distribution

  • 00840194445979 ()
01-1510-0044

  • Surgical screwdriver, reusable
5.5/6.0 Closed Pedicle screw driver, T20, Zimmer Hudson
ORTHOPEDIATRICS CORP.
01-1301-6043
In Commercial Distribution

  • 00840194445849 ()
01-1301-6043

  • 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, Long
ORTHOPEDIATRICS CORP.
01-1510-0026
In Commercial Distribution

  • 00840194429016 ()
01-1510-0026

  • 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
Cervical Final Driver
AMEDICA CORPORATION
A
In Commercial Distribution

  • M555910025005 ()
91.002.5005

  • Internal spinal fixation procedure kit, single-use
Casper Pin Driver
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555910021005 ()
91.002.1005

  • Internal spinal fixation procedure kit, reusable
Final Tightening Driver
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555507000003 ()
50-7000-003

  • Internal spinal fixation procedure kit, reusable
Driver, Polyaxial, 11in
AMEDICA CORPORATION
X
Not in Commercial Distribution

  • M555503000011 ()

  • Length: 11 Inch
50-3000-011

  • Internal spinal fixation procedure kit, reusable
Driver, Polyaxial, Reduction, Long
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555503000009 ()
50-3000-009

  • Internal spinal fixation procedure kit, reusable
Driver, Polyaxial, Long
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555503000008 ()
50-3000-008

  • Internal spinal fixation procedure kit, reusable
Driver, Headless, 10in
AMEDICA CORPORATION
C
Not in Commercial Distribution

  • M555503000007 ()
50-3000-007

  • Internal spinal fixation procedure kit, reusable
120° Adolescent Straight Plate, 16-Hole
ORTHOPEDIATRICS CORP.
00-3002-3216
In Commercial Distribution

  • 00840194473347 ()
00-3002-3216

  • Femoral neck fixation plate/sleeve
120° Adolescent Straight Plate, 15-Hole
ORTHOPEDIATRICS CORP.
00-3002-3215
In Commercial Distribution

  • 00840194473330 ()
00-3002-3215

  • Femoral neck fixation plate/sleeve
120° Adolescent Straight Plate, 14-Hole
ORTHOPEDIATRICS CORP.
00-3002-3214
In Commercial Distribution

  • 00840194473323 ()
00-3002-3214

  • Femoral neck fixation plate/sleeve
120° Adolescent Straight Plate, 13-Hole
ORTHOPEDIATRICS CORP.
00-3002-3213
In Commercial Distribution

  • 00840194473316 ()
00-3002-3213

  • Femoral neck fixation plate/sleeve
120° Adolescent Straight Plate, 12-Hole
ORTHOPEDIATRICS CORP.
00-3002-3212
In Commercial Distribution

  • 00840194473309 ()
00-3002-3212

  • Femoral neck fixation plate/sleeve
120° Adolescent Straight Plate, 11-Hole
ORTHOPEDIATRICS CORP.
00-3002-3211
In Commercial Distribution

  • 00840194473293 ()
00-3002-3211

  • Femoral neck fixation plate/sleeve
120° Adolescent Straight Plate, 10-Hole
ORTHOPEDIATRICS CORP.
00-3002-3210
In Commercial Distribution

  • 00840194473286 ()
00-3002-3210

  • Femoral neck fixation plate/sleeve
120° Adolescent Straight Plate, 9-Hole
ORTHOPEDIATRICS CORP.
00-3002-3209
In Commercial Distribution

  • 00840194473279 ()
00-3002-3209

  • Femoral neck fixation plate/sleeve
120° Adolescent Straight Plate, 8-Hole
ORTHOPEDIATRICS CORP.
00-3002-3208
In Commercial Distribution

  • 00840194473262 ()
00-3002-3208

  • Femoral neck fixation plate/sleeve
120° Adolescent Straight Plate, 7-Hole
ORTHOPEDIATRICS CORP.
00-3002-3207
In Commercial Distribution

  • 00840194473255 ()
00-3002-3207

  • Femoral neck fixation plate/sleeve
120° Adolescent Straight Plate, 6-Hole
ORTHOPEDIATRICS CORP.
00-3002-3206
In Commercial Distribution

  • 00840194473248 ()
00-3002-3206

  • Femoral neck fixation plate/sleeve
120° Adolescent Straight Plate, 5-Hole
ORTHOPEDIATRICS CORP.
00-3002-3205
In Commercial Distribution

  • 00840194473231 ()
00-3002-3205

  • Femoral neck fixation plate/sleeve
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