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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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ROMEO 2 INSTRUMENTATION - 07640178972131

SCREWDRIVER CONICAL
SpineArt SA
SPE-IN 00 25-N
In Commercial Distribution

  • 07640178972131 ()
SPE-IN 00 25-N

  • Surgical screwdriver, reusable

ROMEO 2 INSTRUMENTATION - 07640178972124

SCREWDRIVER FLAT
SpineArt SA
SPE-IN 00 24-N
In Commercial Distribution

  • 07640178972124 ()
SPE-IN 00 24-N

  • Surgical screwdriver, reusable

Drive Rail System - 00817867020801

RAIL ASSEMBLY TOOL
ORTHOPEDIATRICS CORP.
29-0050
In Commercial Distribution

  • 00817867020801 ()
29-0050

  • External orthopaedic fixation system, reusable

Drive Rail System - 00817867020788

3/16" HEX DRIVER
ORTHOPEDIATRICS CORP.
29-0019
In Commercial Distribution

  • 00817867020788 ()
29-0019

  • Surgical torque wrench, reusable

Drive Rail System - 00817867020764

10 mm BOLT DRIVER
ORTHOPEDIATRICS CORP.
29-0017
In Commercial Distribution

  • 00817867020764 ()
29-0017

  • Surgical torque wrench, reusable

Drive Rail System - 00817867020733

3/16" L-HEX DRIVER
ORTHOPEDIATRICS CORP.
29-0010
In Commercial Distribution

  • 00817867020733 ()
29-0010

  • Surgical torque wrench, reusable

Sklar® - 10649111362996

MALLET 46OZ 10 1/2" SOLID HEAD
SKLAR CORPORATION
40-5950
In Commercial Distribution

  • 10649111362996 ()


  • Surgical mallet

Sklar® - 10649111360176

ORTHOPEDIC MALLET 10 1/2" 32OZ
SKLAR CORPORATION
40-5930
In Commercial Distribution

  • 10649111360176 ()


  • Surgical mallet

Sklar® - 10649111359767

NYLON MALLET 9 1/2" 35MM
SKLAR CORPORATION
40-5927
In Commercial Distribution

  • 10649111359767 ()


  • Surgical mallet

Sklar® - 10649111359293

MALLET W/2 PLAST SURFACES
SKLAR CORPORATION
40-5925
In Commercial Distribution

  • 10649111359293 ()


  • Surgical mallet

Sklar® - 10649111357251

STEEL BONE MALLET W/HOOK HANDL
SKLAR CORPORATION
40-5910
In Commercial Distribution

  • 10649111357251 ()


  • Surgical mallet

Sklar® - 10649111352645

LUCAE BONE MALLET SM 8OZ 8"
SKLAR CORPORATION
40-5875
In Commercial Distribution

  • 10649111352645 ()


  • Surgical mallet

Sklar® - 10649111352638

LUCAE MALLET 7.5" 19MM 7OZ
SKLAR CORPORATION
40-5874
In Commercial Distribution

  • 10649111352638 ()


  • Surgical mallet

Sklar® - 10649111352010

SKLAR MALLET W/REPL PLST DISCS
SKLAR CORPORATION
40-5870
In Commercial Distribution

  • 10649111352010 ()


  • Surgical mallet

5MS - 00817906029994

Lag Screw Countersink, 2.0/2.5
IN2BONES USA, LLC
P06 N0691
In Commercial Distribution

  • 00817906029994 ()
P06 N0691

  • Orthopaedic implant driver

5MS - 00817906029987

Lag Screw Drill, Cannulated 1.6
IN2BONES USA, LLC
P06 N0681
In Commercial Distribution

  • 00817906029987 ()
P06 N0681

  • Orthopaedic implant driver

5MS - 00817906029970

Lag Screw Driver, T7 Cannulated
IN2BONES USA, LLC
P06 N0671
In Commercial Distribution

  • 00817906029970 ()
P06 N0671

  • Orthopaedic implant driver

5MS - 00817906029963

LAG SCREW COUNTERSINK, HUDSON, Ø5.0
IN2BONES USA, LLC
P06 N0571
In Commercial Distribution

  • 00817906029963 ()
P06 N0571

  • Orthopaedic implant driver

5MS - 00817906029956

LAG SCREW DRILL, CANNULATED, HUDSON, Ø4.8
IN2BONES USA, LLC
P06 N0562
In Commercial Distribution

  • 00817906029956 ()
P06 N0562

  • Orthopaedic implant driver

5MS - 00817906029949

LAG SCREW DRILL, CANNULATED, HUDSON, Ø3.3
IN2BONES USA, LLC
P06 N0561
In Commercial Distribution

  • 00817906029949 ()
P06 N0561

  • Orthopaedic implant driver

5MS - 00817906029925

LAG SCREW COUNTERSINK, Ø6.7
IN2BONES USA, LLC
P06 N0521
In Commercial Distribution

  • 00817906029925 ()
P06 N0521

  • Orthopaedic implant driver

5MS - 00817906029918

LAG SCREW COUNTERSINK, Ø4.0/Ø5.0
IN2BONES USA, LLC
P06 N0511
In Commercial Distribution

  • 00817906029918 ()
P06 N0511

  • Orthopaedic implant driver

5MS - 00817906029901

LAG SCREW COUNTERSINK, Ø3.0
IN2BONES USA, LLC
P06 N0501
In Commercial Distribution

  • 00817906029901 ()
P06 N0501

  • Orthopaedic implant driver

5MS - 00817906029895

LAG SCREW DRILL, CANNULATED, Ø4.8
IN2BONES USA, LLC
P06 N0471
In Commercial Distribution

  • 00817906029895 ()
P06 N0471

  • Orthopaedic implant driver

5MS - 00817906029888

LAG SCREW DRILL, CANNULATED, Ø3.3
IN2BONES USA, LLC
P06 N0461
In Commercial Distribution

  • 00817906029888 ()
P06 N0461

  • Orthopaedic implant driver

5MS - 00817906029871

LAG SCREW DRILL, CANNULATED, Ø2.7
IN2BONES USA, LLC
P06 N0451
In Commercial Distribution

  • 00817906029871 ()
P06 N0451

  • Orthopaedic implant driver

5MS - 00817906029864

LAG SCREW DRILL, CANNULATED, Ø2.1
IN2BONES USA, LLC
P06 N0441
In Commercial Distribution

  • 00817906029864 ()
P06 N0441

  • Orthopaedic implant driver

5MS - 00817906029857

LAG SCREW DRIVER, T15, CANNULATED
IN2BONES USA, LLC
P06 N0421
In Commercial Distribution

  • 00817906029857 ()
P06 N0421

  • Orthopaedic implant driver

5MS - 00817906029840

LAG SCREW DRIVER, T8, CANNULATED
IN2BONES USA, LLC
P06 N0411
In Commercial Distribution

  • 00817906029840 ()
P06 N0411

  • Orthopaedic implant driver

PathFinder NXT® - 00889024336384

No Description
ZIMMER SPINE, INC.
3558-2
In Commercial Distribution

  • 00889024336384 ()
3558-2

  • Surgical screwdriver, reusable

PathFinder NXT® - 00889024336377

No Description
ZIMMER SPINE, INC.
3558-1
In Commercial Distribution

  • 00889024336377 ()
3558-1

  • Surgical screwdriver, reusable

T-LIFT - 00190361023739

SQUARE CONNECT DRIVER SHAFT, T-LIFT
SPINEFRONTIER, INC.
14-05000
In Commercial Distribution

  • 00190361023739 ()


  • Polymeric spinal interbody fusion cage

SacroFuse - 00190361023647

DRIVER, GEN II INSERTER, SACROFUSE
SPINEFRONTIER, INC.
14-42003
In Commercial Distribution

  • 00190361023647 ()

  • Outer Diameter: 8 Millimeter


  • Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated

SacroFuse - 00190361023272

IMPACT SHAFT-DRIVER, INSERTER, SACROFUSE
SPINEFRONTIER, INC.
14-42001
In Commercial Distribution

  • 00190361023272 ()


  • Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated

SacroFuse - 00190361023265

RETENTION SHAFT, INSERTER, SACROFUSE
SPINEFRONTIER, INC.
14-42000
In Commercial Distribution

  • 00190361023265 ()


  • Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated

T-LIFT - 00190361023210

SQUARE CONNECT DRIVER SHAFT, T-LIFT, 14 DEG
SPINEFRONTIER, INC.
14-05005
In Commercial Distribution

  • 00190361023210 ()


  • Polymeric spinal interbody fusion cage

N/A - 03596010026477

DRIVER SILK SCREW 1.5MM
Smith & Nephew, Inc.
014815
In Commercial Distribution

  • 03596010026477 ()
014815

  • Orthopaedic implant driver

NA - 03596010024664

DRVR FIXATION POST W/HLDR.
Smith & Nephew, Inc.
013124
In Commercial Distribution

  • 03596010024664 ()
013124

  • Orthopaedic implant driver

Reform TI Pedicle Screw System - 00840019929172

Polyaxial Driver
PRECISION SPINE, INC.
39-SP-0720
In Commercial Distribution

  • 00840019929172 ()
39-SP-0720

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Reform TI Pedicle Screw System - 00840019929165

Retention Bone-Screw Driver
PRECISION SPINE, INC.
39-SP-0610
In Commercial Distribution

  • 00840019929165 ()
39-SP-0610

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Reform Pedicle Screw System - 00840019928809

Driver with Mechanical Lock
PRECISION SPINE, INC.
HXX-39-0001
In Commercial Distribution

  • 00840019928809 ()
HXX-39-0001

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Reform Pedicle Screw System - 00840019928748

MIS Polyaxial Screw Driver
PRECISION SPINE, INC.
39-SP-0710
In Commercial Distribution

  • 00840019928748 ()
39-SP-0710

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Reform Pedicle Screw System - 00840019928731

Polyaxial Driver
PRECISION SPINE, INC.
39-SP-0700
In Commercial Distribution

  • 00840019928731 ()
39-SP-0700

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Reform Pedicle Screw System - 00840019928724

Dual-Side Lock Screw Driver
PRECISION SPINE, INC.
39-SP-0603
In Commercial Distribution

  • 00840019928724 ()
39-SP-0603

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Reform Pedicle Screw System - 00840019928717

Lock Screw Retention Driver
PRECISION SPINE, INC.
39-SP-0602
In Commercial Distribution

  • 00840019928717 ()
39-SP-0602

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Reform Pedicle Screw System - 00840019928700

Retention Bone-Screw Driver
PRECISION SPINE, INC.
39-SP-0601
In Commercial Distribution

  • 00840019928700 ()
39-SP-0601

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Reform MC Screw System - 00840019927482

Modular Screw Driver
PRECISION SPINE, INC.
59-MS-0700
In Commercial Distribution

  • 00840019927482 ()
59-MS-0700

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Reform POCT System - 00840019926584

T15 Torque Driver
PRECISION SPINE, INC.
55-IN-0121
In Commercial Distribution

  • 00840019926584 ()
55-IN-0121

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Reform POCT System - 00840019926577

Single Sided Cap Screw Retention Driver
PRECISION SPINE, INC.
55-IN-0119
In Commercial Distribution

  • 00840019926577 ()
55-IN-0119

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Reform POCT System - 00840019926423

Adjustment Driver
PRECISION SPINE, INC.
55-IN-0060
In Commercial Distribution

  • 00840019926423 ()
55-IN-0060

  • Orthopaedic surgical procedure kit, non-medicated, reusable
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