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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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STERIZO Total Knee System - B565M330140451

UC CR Tibial Insert Size 5 - 15mm
CPM Medical Consultants, LLC
Rev A
In Commercial Distribution

  • B565M330140451 ()
M-3301-4045

  • Cruciate-retaining total knee prosthesis

STERIZO Total Knee System - B565M330140351

UC CR Tibial Insert Size 5 - 13mm
CPM Medical Consultants, LLC
Rev A
In Commercial Distribution

  • B565M330140351 ()
M-3301-4035

  • Cruciate-retaining total knee prosthesis

Tibial Revision Platform - B565M32124540R1

Tibial Augment Trial SZ 5 10mm Right
CPM Medical Consultants, LLC
Rev A
In Commercial Distribution

  • B565M32124540R1 ()
M-3212-4510-R

  • Posterior-stabilized total knee prosthesis

Tibial Revision Platform - B565M32124515R1

Tibial Augment Trial SZ 5 15mm Right
CPM Medical Consultants, LLC
Rev A
In Commercial Distribution

  • B565M32124515R1 ()
M-3212-4515-R

  • Posterior-stabilized total knee prosthesis

Tibial Revision Platform - B565M32124515L1

Tibial Augment Trial SZ 5 15mm Left
CPM Medical Consultants, LLC
Rev A
In Commercial Distribution

  • B565M32124515L1 ()
M-3212-4515-L

  • Posterior-stabilized total knee prosthesis

TIBIAL REVISON PLATFORM - B565M32124510R1

TIBIAL AUGMENT TRIAL SZ 5 10MM RIGHT
CPM Medical Consultants, LLC
REV C
In Commercial Distribution

  • B565M32124510R1 ()
M-3212-4510-R

  • Posterior-stabilized total knee prosthesis

Tibial Revision Platform - B565M32124510L1

Tibial Augment Trial SZ 5 10mm Left
CPM Medical Consultants, LLC
Rev A
In Commercial Distribution

  • B565M32124510L1 ()
M-3212-4510-L

  • Posterior-stabilized total knee prosthesis

TIBIAL REVISON PLATFORM - B565M32124505R1

TIBIAL AUGMENT TRIAL SZ 5 5MM RIGHT
CPM Medical Consultants, LLC
REV C
In Commercial Distribution

  • B565M32124505R1 ()
M-3212-4505-R

  • Posterior-stabilized total knee prosthesis

TIBIAL REVISON PLATFORM - B565M32124505L1

TIBIAL AUGMENT TRIAL SZ 5 5MM LEFT
CPM Medical Consultants, LLC
REV C
In Commercial Distribution

  • B565M32124505L1 ()
M-3212-4505-L

  • Posterior-stabilized total knee prosthesis

Drive Rail - 00817867020191

Clamp, 7 Hole Stacked (5, 2 Config)
ORTHOPEDIATRICS CORP.
20-3052
Not in Commercial Distribution

  • 00817867020191 ()
20-3052

  • External orthopaedic fixation system, single-use
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