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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Trial Femoral Component S3 - LEFT
Medacta International SA
02.12.10.0005
In Commercial Distribution

  • 07630971201965 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Trial Femoral Component S2 - RIGHT
Medacta International SA
02.12.10.0004
In Commercial Distribution

  • 07630971201958 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Trial Femoral Component S2 - LEFT
Medacta International SA
02.12.10.0003
In Commercial Distribution

  • 07630971201941 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Trial Femoral Component S1 - RIGHT
Medacta International SA
02.12.10.0002
In Commercial Distribution

  • 07630971201934 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Trial Femoral Component S1 - LEFT
Medacta International SA
02.12.10.0001
In Commercial Distribution

  • 07630971201927 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Femoral Intramedullary rod 8 mm
Medacta International SA
1.100
In Commercial Distribution

  • 07630971215047 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Trial Femoral Component S1+ - LEFT
Medacta International SA
02.12.10.0301
In Commercial Distribution

  • 07630971211193 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Size 4 Right Femoral PS
CPM Medical Consultants, LLC
Rev A
In Commercial Distribution

  • B565M310122041 ()
M-3101-2204

  • Cruciate-retaining total knee prosthesis
Size 3 Right Femoral PS
CPM Medical Consultants, LLC
Rev A
In Commercial Distribution

  • B565M310122031 ()
M-3101-2203

  • Cruciate-retaining total knee prosthesis
RETROSCREW, FEMORAL 10 X 20MM
ARTHREX, INC.
AR-1586FRB-10
In Commercial Distribution

  • 00888867019140 ()
  • M150AR1586FRB101 ()
AR-1586FRB-10

  • Bioabsorbable orthopaedic bone screw
RETROSCREW, FEMORAL 9 X 20MM
ARTHREX, INC.
AR-1586FRB-09
In Commercial Distribution

  • 00888867019133 ()
  • M150AR1586FRB091 ()
AR-1586FRB-09

  • Bioabsorbable orthopaedic bone screw
RETROSCREW, FEMORAL 8 X 20MM
ARTHREX, INC.
AR-1586FR-08
In Commercial Distribution

  • 00888867019089 ()
  • M150AR1586FR082 ()
AR-1586FR-08

  • Orthopaedic bone screw (non-sliding)
FOOTPRINT FEMORAL ACL GUIDE, RIGHT
ARTHREX, INC.
AR-1510FR
In Commercial Distribution

  • 00888867018334 ()
AR-1510FR

  • Surgical drill guide, reusable
MARKING HOOK, FEMORAL ACL, CURVED
ARTHREX, INC.
AR-1510F-01
In Commercial Distribution

  • 00888867018280 ()
AR-1510F-01

  • Surgical drill guide, reusable
IBALANCE TKA, FEMORAL PEG DRILL
ARTHREX, INC.
AR-613-70
In Commercial Distribution

  • 00888867116795 ()
AR-613-70

  • Surgical drill guide, reusable
iBALANCE TKA, FEMORAL ADJUSTMENT BLOCK
ARTHREX, INC.
AR-613-47
In Commercial Distribution

  • 00888867116481 ()
AR-613-47

  • Surgical drill guide, reusable
iBALANCE TKA, FEMORAL ALIGNMENT GUIDE
ARTHREX, INC.
AR-613-42
In Commercial Distribution

  • 00888867116436 ()
AR-613-42

  • Orthopaedic fixation implant alignment tool
iBALANCE TKA, FEMORAL SIZING STYLUS
ARTHREX, INC.
AR-613-24
In Commercial Distribution

  • 00888867116238 ()
AR-613-24

  • Orthopaedic fixation implant alignment tool
IBALANCE TKA, FEMORAL HOLE SAW
ARTHREX, INC.
AR-603-73
In Commercial Distribution

  • 00888867112117 ()
AR-603-73

  • Suturing unit, single-use
DRILL GUIDE, FEMORAL OSTEOTOMY PLATE
ARTHREX, INC.
AR-13332
In Commercial Distribution

  • 00888867089150 ()
AR-13332

  • Surgical drill guide, reusable
13" Femoral Neck Elevator, 70mm
Surgical Direct, Inc.
SD14709-2000
In Commercial Distribution

  • B382SD1470920000 ()
SD14709-2000

  • Periosteal elevator, reusable
28mm FEMORAL HEAD, OTI, -5mm
DJO, LLC
402-28-500
In Commercial Distribution

  • 00888912076531 ()


  • Metallic femoral head prosthesis
ACF, Distal Femoral Cutting block
ARTHREX, INC.
SP-613-44
In Commercial Distribution

  • 00888867285651 ()
SP-613-44

  • Joint prosthesis implantation kit, reusable
iBalance TKA Locking Femoral Impactor
ARTHREX, INC.
AR-613-49NT
Not in Commercial Distribution

  • 00888867284364 ()
AR-613-49NT

  • Orthopaedic implant impactor, reusable
ACF, Distal Femoral Alignment Guide
ARTHREX, INC.
SP-643-42
In Commercial Distribution

  • 00888867275553 ()
SP-643-42

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Sphere Femoral S6+ Instrument Set
Medacta International SA
11.01116
In Commercial Distribution

  • 07630030878701 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Sphere Femoral S5+ Instrument Set
Medacta International SA
11.01115
In Commercial Distribution

  • 07630030878695 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Sphere Femoral S4+ Instrument Set
Medacta International SA
11.01114
In Commercial Distribution

  • 07630030878688 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Sphere Femoral S3+ Instrument Set
Medacta International SA
11.01113
In Commercial Distribution

  • 07630030878671 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Sphere Femoral S2+ Instrument Set
Medacta International SA
11.01112
In Commercial Distribution

  • 07630030878664 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Sphere Femoral S1+ Instrument Set
Medacta International SA
11.01111
In Commercial Distribution

  • 07630030878657 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Sphere Femoral S7 Instrument Set
Medacta International SA
11.01017
In Commercial Distribution

  • 07630030878527 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Sphere Femoral S6 Instrument Set
Medacta International SA
11.01016
In Commercial Distribution

  • 07630030878510 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Sphere Femoral S5 Instrument Set
Medacta International SA
11.01015
In Commercial Distribution

  • 07630030878503 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Sphere Femoral S4 Instrument Set
Medacta International SA
11.01014
In Commercial Distribution

  • 07630030878497 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Sphere Femoral S3 Instrument Set
Medacta International SA
11.01013
In Commercial Distribution

  • 07630030878480 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Sphere Femoral S2 Instrument Set
Medacta International SA
11.01012
In Commercial Distribution

  • 07630030878473 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Sphere Femoral S1 Instrument Set
Medacta International SA
11.01011
In Commercial Distribution

  • 07630030878466 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
MARKING HOOK, LEFT PCL FEMORAL
ARTHREX, INC.
AR-1847
In Commercial Distribution

  • 00888867021792 ()
AR-1847

  • Soft-tissue surgical hook, reusable
RETROSCREW, FEMORAL 8 X 20MM
ARTHREX, INC.
AR-1586FRB-08
In Commercial Distribution

  • 00888867019126 ()
  • M150AR1586FRB081 ()
AR-1586FRB-08

  • Bioabsorbable orthopaedic bone screw
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