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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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HYBRID FIXATOR SYSTEM - 18032568860450

HYBRID COUPLING WITH BALL-JOINT
ORTHOFIX SRL
1
In Commercial Distribution

  • 18032568860450 ()
80050

  • External orthopaedic fixation system, reusable

TiLock - M719GLC4630

Cannulated Drill with Shoulder
Genesys Orthopedics Systems LLC
1
In Commercial Distribution

  • M719GLC4630 ()
GLC463

  • Bone-screw internal spinal fixation system, non-sterile

TiLock - M719GL4170

Distractor with Serrated Handles
Genesys Orthopedics Systems LLC
1
In Commercial Distribution

  • M719GL4170 ()
GL417

  • Bone-screw internal spinal fixation system, non-sterile

TiLock - M719GL4160

Compressor with Serrated Handles
Genesys Orthopedics Systems LLC
1
In Commercial Distribution

  • M719GL4160 ()
GL416

  • Bone-screw internal spinal fixation system, non-sterile

JOURNEY II - 00885556685662

BOX OSTEOTOME WITH BACKSLAP
Smith & Nephew, Inc.
E0015382-1
In Commercial Distribution

  • 00885556685662 ()
E0015382-1

  • Orthopaedic osteotome

Legion - 00885556684986

TIBIAL MILL WITH HANDLE
Smith & Nephew, Inc.
E0015348-1
In Commercial Distribution

  • 00885556684986 ()
E0015348-1

  • Bone-resection orthopaedic reamer, reusable

JOURNEY II - 00885556684450

BOX OSTEOTOME WITH BACKSLAP
Smith & Nephew, Inc.
E0015314-18
In Commercial Distribution

  • 00885556684450 ()
E0015314-18

  • Orthopaedic osteotome

Legion - 00885556659267

FEMORAL STYLUS WITH T-HANDLE
Smith & Nephew, Inc.
E0014993-11
Not in Commercial Distribution

  • 00885556659267 ()
E0014993-11

  • Orthopaedic prosthesis implantation positioning instrument, reusable

Peri-Loc - 00885556654927

K-WIRE WITH LOOP END
Smith & Nephew, Inc.
E0015109-3
In Commercial Distribution

  • 00885556654927 ()
E0015109-3

  • Orthopaedic prosthesis implantation positioning instrument, reusable

Trigen - 00885556654521

IMPACTOR WITH QUICK CONNECT
Smith & Nephew, Inc.
E0014947-1
Not in Commercial Distribution

  • 00885556654521 ()
E0014947-1

  • Orthopaedic implant impactor, reusable
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