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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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INSTRUMENT - 07613327234626

XCELERATE UNIVERSAL BLOCK PEGLESS
Howmedica Osteonics Corp.
8000-3309
In Commercial Distribution

  • 07613327234626 ()

  • Size: 9
8000-3309

  • Orthopaedic prosthesis implantation positioning instrument, reusable

INSTRUMENT - 07613327234275

PASSPORT AR KNEE INSTRUMENTATION AR FEMORAL RESECTION GUIDE
Howmedica Osteonics Corp.
7650-5109
In Commercial Distribution

  • 07613327234275 ()

  • Size: 9
7650-5109

  • Orthopaedic prosthesis implantation positioning instrument, reusable

DISTRACTION, INTERNAL - 00888118129161

PLATE, LEFORT 1, ADJ MIDFACE, BUTTRESS, CONE CONNECT, 5 MM AP, 3 MM BRG, TI-6AL-4V
KLS-Martin L.P.
51-401-03-09
In Commercial Distribution

  • 00888118129161 ()

  • 9 HOLE


  • Implantable craniofacial bone distractor

DISTRACTION, INTERNAL - 00888118129147

PLATE, LEFORT 1, ADJ MIDFACE, BUTTRESS, CONE CONNECT, 5 MM AP, 9 MM BRG, TI-6AL-4V
KLS-Martin L.P.
51-401-09-09
In Commercial Distribution

  • 00888118129147 ()

  • 9 HOLE


  • Implantable craniofacial bone distractor

INSTRUMENT - 07613327233865

UNIVERSAL NOTCH PREPARATION GUIDE
Howmedica Osteonics Corp.
7650-3369
In Commercial Distribution

  • 07613327233865 ()

  • Size: 9
7650-3369

  • Orthopaedic prosthesis implantation positioning instrument, reusable

INSTRUMENT - 07613327233698

PASSPORT RESURFACING PATELLA SYSTEM PATELLA DRILL TEMPLATE
Howmedica Osteonics Corp.
7650-1709
In Commercial Distribution

  • 07613327233698 ()

  • Size: 9
7650-1709

  • Surgical drill guide, reusable

INSTRUMENT - 07613327233070

SERIES 7000 A/P SIZING GUIDE
Howmedica Osteonics Corp.
7502-0009
In Commercial Distribution

  • 07613327233070 ()

  • Size: 9
7502-0009

  • Orthopaedic prosthesis implantation positioning instrument, reusable

INSTRUMENT - 07613327232936

SERIES 7000 CUTTING GUIDE
Howmedica Osteonics Corp.
7297-0009
In Commercial Distribution

  • 07613327232936 ()

  • Size: 9
7297-0009

  • Orthopaedic prosthesis implantation positioning instrument, reusable

DISTRACTION, INTERNAL - 00888118109484

PLATE, LEFORT 1, ADJ MIDFACE, BUTTRESS, CONE CONNECT, 5 MM AP, 9 MM BRG, TI-6AL-4V
KLS-Martin L.P.
99-474-84-09
In Commercial Distribution

  • 00888118109484 ()

  • 9 HOLE


  • Implantable craniofacial bone distractor

DISTRACTION, INTERNAL - 00888118109477

PLATE, LEFORT 1, ADJ MIDFACE, BUTTRESS, CONE CONNECT, 5 MM AP, 6 MM BRG, TI-6AL-4V
KLS-Martin L.P.
99-474-84-08
In Commercial Distribution

  • 00888118109477 ()

  • 9 HOLE


  • Implantable craniofacial bone distractor

DISTRACTION, INTERNAL - 00888118109460

PLATE, LEFORT 1, ADJ MIDFACE, BUTTRESS, CONE CONNECT, 5 MM AP, 3 MM BRG, TI-6AL-4V
KLS-Martin L.P.
99-474-84-07
In Commercial Distribution

  • 00888118109460 ()

  • 9 HOLE


  • Implantable craniofacial bone distractor

DISTRACTION, INTERNAL - 00888118129154

PLATE, LEFORT 1, ADJ MIDFACE, BUTTRESS, CONE CONNECT, 5 MM AP, 6 MM BRG, TI-6AL-4V
KLS-Martin L.P.
51-401-06-09
In Commercial Distribution

  • 00888118129154 ()

  • 9 HOLE


  • Implantable craniofacial bone distractor

INSTRUMENT - 07613327260205

TIBIAL PUNCH THRU BASEPLATE
Howmedica Osteonics Corp.
3750-0009-A
In Commercial Distribution

  • 07613327260205 ()

  • Size: 9
3750-0009-A

  • Surgical implant template, reusable

INSTRUMENT - 07613327252606

ACCOLADE II BROACH
Howmedica Osteonics Corp.
1020-5209
In Commercial Distribution

  • 07613327252606 ()

  • Size: 9
1020-5209

  • Orthopaedic broach

INSTRUMENT - 07613327252347

SCORPIO / NRG 4-IN-1 CUTTING BLOCK
Howmedica Osteonics Corp.
8010-2009
In Commercial Distribution

  • 07613327252347 ()

  • Size: 9
8010-2009

  • Orthopaedic prosthesis implantation positioning instrument, reusable

DISTRACTION, INTERNAL, STERILE - 00888118104434

PLATE, LEFORT 1, ADJ MIDFACE, BUTTRESS, 2 AP HOLES, 10 MM BRG, 1.5-1.8 MM SCREW, TI-6AL-4V
KLS-Martin L.P.
51-401-32-71
Not in Commercial Distribution

  • 00888118104434 ()

  • 9 HOLE


  • Implantable craniofacial bone distractor

DISTRACTION, INTERNAL, STERILE - 00888118104427

PLATE, LEFORT 1, ADJ MIDFACE, BUTTRESS, 3 AP HOLES, 3 MM BRG, 1.5-1.8 MM SCREW, TI-6AL-4V
KLS-Martin L.P.
51-401-31-71
In Commercial Distribution

  • 00888118104427 ()

  • 9 HOLE


  • Implantable craniofacial bone distractor

DISTRACTION, INTERNAL, STERILE - 00888118104410

PLATE, LEFORT 1, ADJ MIDFACE, BUTTRESS, 2 AP HOLES, 3 MM BRG, 1.5-1.8 MM SCREW, TI-6AL-4V
KLS-Martin L.P.
51-401-30-71
In Commercial Distribution

  • 00888118104410 ()

  • 9 HOLE


  • Implantable craniofacial bone distractor

DFS HYBRID RING FIXATOR SYSTEM - 00888480153313

No Description
Biomet Orthopedics, LLC
13140
In Commercial Distribution

  • 00888480153313 ()

  • 9 MM
13140

  • External orthopaedic fixation system, single-use

Z1™ Hip System - 00887868576195

No Description
Zimmer, Inc.
611103090
In Commercial Distribution

  • 00887868576195 ()

  • Size 9
611103090

  • Coated hip femur prosthesis, modular

Z1™ Hip System - 00887868575808

No Description
Zimmer, Inc.
611203090
In Commercial Distribution

  • 00887868575808 ()

  • Size 9
611203090

  • Coated hip femur prosthesis, modular

Z1™ Hip System - 00887868575679

No Description
Zimmer, Inc.
611202090
In Commercial Distribution

  • 00887868575679 ()

  • Size 9
611202090

  • Coated hip femur prosthesis, modular

Impingement Rod - 00887868569210

No Description
Biomet Orthopedics, LLC
909935
In Commercial Distribution

  • 00887868569210 ()

  • 9 mm
909935

  • Surgical depth gauge, reusable

Double Bundle - 00887868568893

No Description
Biomet Orthopedics, LLC
909749
In Commercial Distribution

  • 00887868568893 ()

  • 9 mm
909749

  • Surgical drill guide, reusable

Biomet® General Hip Instruments - 00887868245503

No Description
Biomet Orthopedics, LLC
31-479809
In Commercial Distribution

  • 00887868245503 ()

  • 9 mm
31-479809

  • Orthopaedic cement restrictor sizer

Maestro™ Total Wrist - 00887868239533

No Description
Biomet Orthopedics, LLC
180153
In Commercial Distribution

  • 00887868239533 ()

  • 9 mm
180153

  • Total wrist radius prosthesis

Maestro™ Total Wrist - 00887868239526

No Description
Biomet Orthopedics, LLC
180152
In Commercial Distribution

  • 00887868239526 ()

  • 9 mm
180152

  • Total wrist radius prosthesis

TunneLoc® - 00887868226656

No Description
Biomet Orthopedics, LLC
906513
In Commercial Distribution

  • 00887868226656 ()

  • 9 MM
906513

  • Tendon/ligament bone anchor, non-bioabsorbable

Instrument - 07613327519969

Insignia Hip Stem Broach
Howmedica Osteonics Corp.
8000-7709
In Commercial Distribution

  • 07613327519969 ()

  • Size: 9
8000-7709

  • Orthopaedic broach

MicroLink - 30845854049017

MICROLINK, MCGLAMRY ELEVATOR
Conmed Corporation
ASB-ME
In Commercial Distribution

  • 30845854049017 ()
  • 20845854049010 ()

  • 9 mm
ASB-ME

  • Bone lever/elevator, reusable

POLYAX®FEMORAL PLATE - LEFT - 00887868036941

No Description
Biomet Orthopedics, LLC
8141-31-109
In Commercial Distribution

  • 00887868036941 ()

  • 9 HOLE
814131109

  • Orthopaedic fixation plate, non-bioabsorbable

POLYAX®FEMORAL PLATE - LEFT - 00887868015601

No Description
Biomet Orthopedics, LLC
1486-05-009
In Commercial Distribution

  • 00887868015601 ()

  • 9 HOLE
148605009

  • Orthopaedic fixation plate, non-bioabsorbable

POLYAX®FEMORAL PLATE - RIGHT - 00887868015557

No Description
Biomet Orthopedics, LLC
1486-04-009
In Commercial Distribution

  • 00887868015557 ()

  • 9 HOLE
148604009

  • Orthopaedic fixation plate, non-bioabsorbable

POLYAX®FEMORAL PLATE - RIGHT - 00887868036897

No Description
Biomet Orthopedics, LLC
8141-30-109
In Commercial Distribution

  • 00887868036897 ()

  • 9 HOLE
814130109

  • Orthopaedic fixation plate, non-bioabsorbable

NA - 00889024089624

No Description
Zimmer, Inc.
47-2358-024-09
In Commercial Distribution

  • 00889024089624 ()

  • 9 Holes
  • Length: 139 Millimeter
47-2358-024-09

  • Orthopaedic fixation plate, non-bioabsorbable

NA - 00889024089570

No Description
Zimmer, Inc.
47-2358-023-09
In Commercial Distribution

  • 00889024089570 ()

  • Length: 139 Millimeter
  • 9 Holes
47-2358-023-09

  • Orthopaedic fixation plate, non-bioabsorbable

NA - 00889024089174

No Description
Zimmer, Inc.
47-2358-012-09
In Commercial Distribution

  • 00889024089174 ()

  • Length: 155 Millimeter
  • 9 Holes
47-2358-012-09

  • Orthopaedic fixation plate, non-bioabsorbable

NA - 00889024089105

No Description
Zimmer, Inc.
47-2358-009-09
In Commercial Distribution

  • 00889024089105 ()

  • Length: 155 Millimeter
  • 9 Holes
47-2358-009-09

  • Orthopaedic fixation plate, non-bioabsorbable

NA - 00889024088931

No Description
Zimmer, Inc.
47-2358-006-09
In Commercial Distribution

  • 00889024088931 ()

  • 9 Holes
  • Length: 150 Millimeter
47-2358-006-09

  • Orthopaedic fixation plate, non-bioabsorbable

NA - 00889024088863

No Description
Zimmer, Inc.
47-2358-005-09
In Commercial Distribution

  • 00889024088863 ()

  • Length: 150 Millimeter
  • 9 Holes
47-2358-005-09

  • Orthopaedic fixation plate, non-bioabsorbable
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