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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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Arthrex® - 00888867117013

iBALANCE TKA TRIALS CASE
ARTHREX, INC.
AR-613-C2
In Commercial Distribution

  • 00888867117013 ()
AR-613-C2

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867117006

iBALANCE TKA INSTRUMENT CASE
ARTHREX, INC.
AR-613-C1
In Commercial Distribution

  • 00888867117006 ()
AR-613-C1

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867116993

IBAL TKA TIB BEA-RING TRL SET,CR +
ARTHREX, INC.
AR-613-ATS
In Commercial Distribution

  • 00888867116993 ()
AR-613-ATS

  • Knee tibia prosthesis trial, reusable

Arthrex® - 00888867116986

IBAL TKA,FEM TRL MOD RT SZ9
ARTHREX, INC.
AR-613-9R
In Commercial Distribution

  • 00888867116986 ()
AR-613-9R

  • Knee femur prosthesis trial, reusable

Arthrex® - 00888867116979

IBAL TKA,FEM TRL,MOD LFT SZ9
ARTHREX, INC.
AR-613-9L
In Commercial Distribution

  • 00888867116979 ()
AR-613-9L

  • Knee femur prosthesis trial, reusable

Arthrex® - 00888867116962

SLAP HAMMER
ARTHREX, INC.
AR-613-99
In Commercial Distribution

  • 00888867116962 ()
AR-613-99

  • Orthopaedic implant impactor, reusable

Arthrex® - 00888867116795

IBALANCE TKA, FEMORAL PEG DRILL
ARTHREX, INC.
AR-613-70
In Commercial Distribution

  • 00888867116795 ()
AR-613-70

  • Surgical drill guide, reusable

Arthrex® - 00888867116788

IBALANCE TKA, 3" HEADLESS THREADED PIN
ARTHREX, INC.
AR-613-7
In Commercial Distribution

  • 00888867116788 ()
AR-613-7

  • Surgical drill guide, reusable

Arthrex® - 00888867116771

IBAL TKA,FEM TRL MOD RT SZ6
ARTHREX, INC.
AR-613-6R
In Commercial Distribution

  • 00888867116771 ()
AR-613-6R

  • Knee femur prosthesis trial, reusable

Arthrex® - 00888867116764

IBAL TKA,FEM TRL,MOD LFT SZ6
ARTHREX, INC.
AR-613-6L
In Commercial Distribution

  • 00888867116764 ()
AR-613-6L

  • Knee femur prosthesis trial, reusable

Arthrex® - 00888867116757

iBALANCE TKA, NOTCH CHISEL
ARTHREX, INC.
AR-613-69
In Commercial Distribution

  • 00888867116757 ()
AR-613-69

  • Orthopaedic implant impactor, reusable

Arthrex® - 00888867116740

iBALANCE TKA, CURVED OSTEOTOME
ARTHREX, INC.
AR-613-66
In Commercial Distribution

  • 00888867116740 ()
AR-613-66

  • Orthopaedic osteotome

Arthrex® - 00888867116733

iBALANCE TKA, DUAL SPIKE PUNCH
ARTHREX, INC.
AR-613-65
In Commercial Distribution

  • 00888867116733 ()
AR-613-65

  • Orthopaedic implant impactor, reusable

Arthrex® - 00888867116726

iBALANCE TKA, RASP
ARTHREX, INC.
AR-613-64
In Commercial Distribution

  • 00888867116726 ()
AR-613-64

  • Bone file/rasp, manual, reusable

Arthrex® - 00888867116672

ADJUSTMENT ROD
ARTHREX, INC.
AR-613-6
In Commercial Distribution

  • 00888867116672 ()
AR-613-6

  • Orthopaedic fixation implant alignment tool

Arthrex® - 00888867116665

IBAL TKA,FEM TRL MOD RT SZ5
ARTHREX, INC.
AR-613-5R
In Commercial Distribution

  • 00888867116665 ()
AR-613-5R

  • Knee femur prosthesis trial, reusable

Arthrex® - 00888867116658

IBAL TKA,FEM TRL,MOD LFT SZ5
ARTHREX, INC.
AR-613-5L
In Commercial Distribution

  • 00888867116658 ()
AR-613-5L

  • Knee femur prosthesis trial, reusable

Arthrex® - 00888867116634

IBAL TKA,FEM CUT BLK,SZ 8
ARTHREX, INC.
AR-613-58
In Commercial Distribution

  • 00888867116634 ()
AR-613-58

  • Surgical drill guide, reusable

Arthrex® - 00888867116627

IBAL TKA,FEM CUT BLK,SZ 7
ARTHREX, INC.
AR-613-57
In Commercial Distribution

  • 00888867116627 ()
AR-613-57

  • Surgical drill guide, reusable

Arthrex® - 00888867116610

IBAL TKA,FEM CUT BLK,SZ 6
ARTHREX, INC.
AR-613-56
In Commercial Distribution

  • 00888867116610 ()
AR-613-56

  • Surgical drill guide, reusable

Arthrex® - 00888867116603

IBAL TKA,FEM CUT BLK,SZ 5
ARTHREX, INC.
AR-613-55
In Commercial Distribution

  • 00888867116603 ()
AR-613-55

  • Surgical drill guide, reusable

Arthrex® - 00888867116597

IBAL TKA,FEM CUT BLK,SZ 4
ARTHREX, INC.
AR-613-54
In Commercial Distribution

  • 00888867116597 ()
AR-613-54

  • Surgical drill guide, reusable

Arthrex® - 00888867116580

IBAL TKA,FEM CUT BLK,SZ 3
ARTHREX, INC.
AR-613-53
In Commercial Distribution

  • 00888867116580 ()
AR-613-53

  • Surgical drill guide, reusable

Arthrex® - 00888867116573

IBAL TKA,FEM CUT BLK,SZ 2
ARTHREX, INC.
AR-613-52
In Commercial Distribution

  • 00888867116573 ()
AR-613-52

  • Surgical drill guide, reusable

Arthrex® - 00888867116535

IBALANCE TKA, SPIKED ALIGNMENT GUIDE
ARTHREX, INC.
AR-613-5
In Commercial Distribution

  • 00888867116535 ()
AR-613-5

  • Orthopaedic fixation implant alignment tool

Arthrex® - 00888867116528

IBAL TKA,FEM TRL MOD RT SZ4
ARTHREX, INC.
AR-613-4R
In Commercial Distribution

  • 00888867116528 ()
AR-613-4R

  • Knee femur prosthesis trial, reusable

Arthrex® - 00888867116511

IBAL TKA,FEM TRL,MOD LFT SZ4
ARTHREX, INC.
AR-613-4L
In Commercial Distribution

  • 00888867116511 ()
AR-613-4L

  • Knee femur prosthesis trial, reusable

Arthrex® - 00888867116504

FEMORAL IMPACTOR ASSEMBLY
ARTHREX, INC.
AR-613-49
In Commercial Distribution

  • 00888867116504 ()
AR-613-49

  • Orthopaedic implant impactor, reusable

Arthrex® - 00888867116498

iBALANCE TKA, MODULAR T-HANDLE
ARTHREX, INC.
AR-613-48
In Commercial Distribution

  • 00888867116498 ()
AR-613-48

  • Surgical instrument handle, non-torque-limiting

Arthrex® - 00888867116481

iBALANCE TKA, FEMORAL ADJUSTMENT BLOCK
ARTHREX, INC.
AR-613-47
In Commercial Distribution

  • 00888867116481 ()
AR-613-47

  • Surgical drill guide, reusable

Arthrex® - 00888867116474

TIBIAL ALIGNMENT GUIDE
ARTHREX, INC.
AR-613-46
In Commercial Distribution

  • 00888867116474 ()
AR-613-46

  • Orthopaedic fixation implant alignment tool

Arthrex® - 00888867116467

iBALANCE TKA, IM ROD, MODULAR
ARTHREX, INC.
AR-613-45
In Commercial Distribution

  • 00888867116467 ()
AR-613-45

  • Orthopaedic fixation implant alignment tool

Arthrex® - 00888867116450

IBALANCE TKA, DISTAL RESECTION GUIDE
ARTHREX, INC.
AR-613-44
In Commercial Distribution

  • 00888867116450 ()
AR-613-44

  • Surgical drill guide, reusable

Arthrex® - 00888867116443

IBALANCE TKA, OFFSET TOWER
ARTHREX, INC.
AR-613-43
In Commercial Distribution

  • 00888867116443 ()
AR-613-43

  • Orthopaedic fixation implant alignment tool

Arthrex® - 00888867116436

iBALANCE TKA, FEMORAL ALIGNMENT GUIDE
ARTHREX, INC.
AR-613-42
In Commercial Distribution

  • 00888867116436 ()
AR-613-42

  • Orthopaedic fixation implant alignment tool

Arthrex® - 00888867116429

IBALANCE TKA, IM DRILL
ARTHREX, INC.
AR-613-41
In Commercial Distribution

  • 00888867116429 ()
AR-613-41

  • Fluted surgical drill bit, reusable

Arthrex® - 00888867116412

IBAL TKA,TIP,MODU-LAR KEEL PUNCH,SZ 6-8
ARTHREX, INC.
AR-613-4
In Commercial Distribution

  • 00888867116412 ()
AR-613-4

  • Orthopaedic implant impactor, reusable

Arthrex® - 00888867116405

IBAL TKA,FEM TRL MOD RT SZ3
ARTHREX, INC.
AR-613-3R
In Commercial Distribution

  • 00888867116405 ()
AR-613-3R

  • Knee femur prosthesis trial, reusable

Arthrex® - 00888867116399

IBAL TKA,FEM TRL,MOD LFT SZ3
ARTHREX, INC.
AR-613-3L
In Commercial Distribution

  • 00888867116399 ()
AR-613-3L

  • Knee femur prosthesis trial, reusable

Arthrex® - 00888867116382

iBALANCE TKA, SPACER BLOCK, 13MM
ARTHREX, INC.
AR-613-38
In Commercial Distribution

  • 00888867116382 ()
AR-613-38

  • Surgical drill guide, reusable

Arthrex® - 00888867116375

iBALANCE TKA, SPACER BLOCK, 12MM
ARTHREX, INC.
AR-613-37
In Commercial Distribution

  • 00888867116375 ()
AR-613-37

  • Surgical drill guide, reusable

Arthrex® - 00888867116368

iBALANCE TKA, SPACER BLOCK, 11MM
ARTHREX, INC.
AR-613-36
In Commercial Distribution

  • 00888867116368 ()
AR-613-36

  • Surgical drill guide, reusable

Arthrex® - 00888867116351

iBALANCE TKA, SPACER BLOCK, 10MM
ARTHREX, INC.
AR-613-35
In Commercial Distribution

  • 00888867116351 ()
AR-613-35

  • Surgical drill guide, reusable

Arthrex® - 00888867116344

iBALANCE TKA, SPACER BLOCK, 9MM
ARTHREX, INC.
AR-613-34
In Commercial Distribution

  • 00888867116344 ()
AR-613-34

  • Surgical drill guide, reusable

Arthrex® - 00888867116337

iBALANCE TKA, SPACER BLOCK, 8MM
ARTHREX, INC.
AR-613-33
In Commercial Distribution

  • 00888867116337 ()
AR-613-33

  • Surgical drill guide, reusable

Arthrex® - 00888867116320

iBALANCE TKA, SPACER BLOCK, +6MM
ARTHREX, INC.
AR-613-32
In Commercial Distribution

  • 00888867116320 ()
AR-613-32

  • Surgical drill guide, reusable

Arthrex® - 00888867116313

TIBIAL IMPACTOR
ARTHREX, INC.
AR-613-30
In Commercial Distribution

  • 00888867116313 ()
AR-613-30

  • Orthopaedic implant impactor, reusable

Arthrex® - 00888867116306

IBAL TKA,TIP,MODU-LAR KEEL PUNCH,SZ 3-5
ARTHREX, INC.
AR-613-3
In Commercial Distribution

  • 00888867116306 ()
AR-613-3

  • Orthopaedic implant impactor, reusable

Arthrex® - 00888867116283

IBAL TKA,FEM TRL,MOD LFT SZ2
ARTHREX, INC.
AR-613-2L
In Commercial Distribution

  • 00888867116283 ()
AR-613-2L

  • Knee femur prosthesis trial, reusable

Arthrex® - 00888867116276

FEMORAL IMPACTOR
ARTHREX, INC.
AR-613-29
In Commercial Distribution

  • 00888867116276 ()
AR-613-29

  • Orthopaedic implant impactor, reusable
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