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 Type Device Class Implantable

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Cadence Total Ankle Resection Instruments
Ascension Orthopedics, Inc.
CADENCERESECT12
Not in Commercial Distribution

  • M248CADENCERESECT121 ()
  • 10381780435099 ()
CADENCERESECT12

  • Instrument tray, reusable
Cadence Trials, Insertion, and Removal Instruments
Ascension Orthopedics, Inc.
CADENCEINSERT12
Not in Commercial Distribution

  • M248CADENCEINSERT121 ()
  • 10381780435082 ()
CADENCEINSERT12

  • Instrument tray, reusable
Katalyst™ Bipolar Radial Head System 24mm Radial Head Sizing Wand
Ascension Orthopedics, Inc.
225924
In Commercial Distribution

  • M2482259241 ()
  • 10381780363965 ()
225924

  • Elbow radius prosthesis
Katalyst™ Bipolar Radial Head System 21mm Radial Head Sizing Wand
Ascension Orthopedics, Inc.
225921
In Commercial Distribution

  • M2482259211 ()
  • 10381780363958 ()
225921

  • Elbow radius prosthesis
Katalyst™ Bipolar Radial Head System 18mm Radial Head Sizing Wand
Ascension Orthopedics, Inc.
225918
In Commercial Distribution

  • M2482259181 ()
  • 10381780363941 ()
225918

  • Elbow radius prosthesis
Katalyst Radial Head Sizing Wand Instruments
Ascension Orthopedics, Inc.
KATALYSTWANDIMP
Not in Commercial Distribution

  • M248KATALYSTWANDIMP1 ()
  • 10381780354604 ()
KATALYSTWANDIMP

  • Elbow radius prosthesis
Retractor Set Modular Shoulder System
Ascension Orthopedics, Inc.
TSSRETRACIMP
Not in Commercial Distribution

  • M248TSSRETRACIMP1 ()
  • 10381780282518 ()
TSSRETRACIMP

  • Self-retaining surgical retractor, reusable
CMC Sizer Instrument Set
Ascension Orthopedics, Inc.
CMCSTD
In Commercial Distribution

  • M248CMCSTD0 ()
  • 10381780282495 ()
CMCSTD

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Allograft Wedge Instrument Set
Ascension Orthopedics, Inc.
WEDGEINST
Not in Commercial Distribution

  • M248WEDGEINST0 ()
  • 10381780282488 ()
WEDGEINST

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Total Foot System Cutters
Ascension Orthopedics, Inc.
RFOOTCUTIMP
Not in Commercial Distribution

  • M248RFOOTCUTIMP0 ()
  • 10381780282471 ()
RFOOTCUTIMP

  • Instrument tray, reusable
PyroSphere® Sizer
Ascension Orthopedics, Inc.
PYRSPHSZINSP
Not in Commercial Distribution

  • M248PYRSPHSZINSP1 ()
  • 10381780282464 ()
PYRSPHSZINSP

  • Surgical implant template, reusable
Pyrocarbon CMC
Ascension Orthopedics, Inc.
PYROSADINSTP
Not in Commercial Distribution

  • M248PYROSADINSTP0 ()
  • 10381780282457 ()
PYROSADINSTP

  • Instrument tray, reusable
CMC Implant Cutters
Ascension Orthopedics, Inc.
CMCCUTRINSTP
Not in Commercial Distribution

  • M248CMCCUTRINSTP1 ()
  • 10381780282433 ()
CMCCUTRINSTP

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Screw System Base Instruments
Ascension Orthopedics, Inc.
CAPINSTP
Not in Commercial Distribution

  • M248CAPINSTP1 ()
  • 10381780282419 ()
CAPINSTP

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Modular Ulnar Head
Ascension Orthopedics, Inc.
ULNAHDINSTP
Not in Commercial Distribution

  • M248ULNAHDINSTP1 ()
  • 10381780282402 ()
ULNAHDINSTP

  • Instrument tray, reusable
Endorelease - Full Instrument Set
Ascension Orthopedics, Inc.
ENDORELINSTP
Not in Commercial Distribution

  • M248ENDORELINSTP0 ()
  • 10381780282396 ()
ENDORELINSTP

  • Arthroscopic surgical procedure kit, non-medicated, reusable
Endorelease - Standard Instrument Set
Ascension Orthopedics, Inc.
ENDORELSTD
Not in Commercial Distribution

  • M248ENDORELSTD0 ()
  • 10381780282389 ()
ENDORELSTD

  • Arthroscopic surgical procedure kit, non-medicated, reusable
1.1MM K-WIRE
Ascension Orthopedics, Inc.
600011
Not in Commercial Distribution

  • M2486000111 ()
  • 10381780281351 ()

  • 152.4mm Length x 1.1mm Diameter
600011

  • Orthopaedic prosthesis implantation positioning instrument, reusable
VIPER/VALT 2.7MM DRILL BIT
Ascension Orthopedics, Inc.
605027
Not in Commercial Distribution

  • M2486050271 ()
  • 10381780281344 ()

  • 3.93" x 0.172" Diameter
605027

  • Fluted surgical drill bit, reusable
VIPER/VALT 2.0MM DRILL BIT
Ascension Orthopedics, Inc.
605020
Not in Commercial Distribution

  • M2486050201 ()
  • 10381780281337 ()

  • 3.93" x 0.172" Diameter
605020

  • Fluted surgical drill bit, reusable
DRILL GUIDE 2.0/2.7MM
Ascension Orthopedics, Inc.
605227
Not in Commercial Distribution

  • M2486052271 ()
  • 10381780281320 ()
605227

  • Surgical drill guide, reusable
VIPER SCREW EXTRACTOR LONG
Ascension Orthopedics, Inc.
605005
Not in Commercial Distribution

  • M2486050051 ()
  • 10381780281313 ()

  • 54.40mm Length x 4.50mm Diameter
605005

  • Orthopaedic implant inserter/extractor, reusable
VIPER SCREW EXTRACTOR SHORT
Ascension Orthopedics, Inc.
605004
Not in Commercial Distribution

  • M2486050041 ()
  • 10381780281306 ()

  • 53.10mm Length x 4.50mm Diameter
605004

  • Orthopaedic implant inserter/extractor, reusable
VALT KEY LOCK DRIVER
Ascension Orthopedics, Inc.
605002
Not in Commercial Distribution

  • M2486050021 ()
  • 10381780281290 ()

  • 60.0mm Length x 30.0mm Width x 7.0mm Height
605002

  • Surgical screwdriver, reusable
VALT PLACEMENT DRIVER
Ascension Orthopedics, Inc.
605001
Not in Commercial Distribution

  • M2486050011 ()
  • 10381780281283 ()

  • 181.5mm Length x 16.00mm Diameter
605001

  • Surgical screwdriver, reusable
VIPER/VALT SCREW CADDY ONLY
Ascension Orthopedics, Inc.
270012
Not in Commercial Distribution

  • M2482700121 ()
  • 10381780281276 ()

  • 4.67" Length x 2.50" Width
270012

  • Instrument tray, reusable
VIPER TRAY CADDY
Ascension Orthopedics, Inc.
270011
Not in Commercial Distribution

  • M2482700111 ()
  • 10381780281269 ()

  • 203.20mm Length x 114.30mm Width
270011

  • Instrument tray, reusable
TRAY ASSEMBLY
Ascension Orthopedics, Inc.
270010
Not in Commercial Distribution

  • M2482700101 ()
  • 10381780281252 ()

  • 20.08" Length x 9.29" Width
270010

  • Instrument tray, reusable
INTERPOSITIONAL SIZER Ø21MM x 21MM
Ascension Orthopedics, Inc.
322121
Not in Commercial Distribution

  • M2483221211 ()
  • 10381780281245 ()

  • 227mm Length x 21.00mm Width x 21.00mm Diameter
322121

  • Orthopaedic prosthesis implantation positioning instrument, reusable
INTERPOSITIONAL SIZER Ø21MM x 10MM
Ascension Orthopedics, Inc.
322110
Not in Commercial Distribution

  • M2483221101 ()
  • 10381780281238 ()

  • 216mm Length x 21.00mm Diameter
322110

  • Orthopaedic prosthesis implantation positioning instrument, reusable
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