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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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SLAP HAMMER
TITAN SPINE, LLC
5210-1036
Not in Commercial Distribution

  • M682521010360 ()

  • Length: 8 Inch
5210-1036

  • Surgical mallet
NO 8 HEXALOBE, U-JOINT DRIVER
TITAN SPINE, LLC
5210-1024
Not in Commercial Distribution

  • M682521010240 ()

  • Length: 5 Inch
5210-1024

  • Orthopaedic inorganic implant inserter/extractor, reusable
NO 8 HEXALOBE, SWIVEL DRIVER
TITAN SPINE, LLC
5210-1005
Not in Commercial Distribution

  • M682521010050 ()

  • Length: 5 Inch
5210-1005

  • Orthopaedic inorganic implant inserter/extractor, reusable
NO 8 HEXALOBE, STRAIGHT DRIVER
TITAN SPINE, LLC
5210-1004
Not in Commercial Distribution

  • M682521010040 ()

  • Length: 5 Inch
5210-1004

  • Orthopaedic inorganic implant inserter/extractor, reusable
S MALLET
TITAN SPINE, LLC
5210-1003
Not in Commercial Distribution

  • M682521010030 ()

  • Width: 2 Inch
  • Length: 7 Inch
5210-1003

  • Surgical mallet
Chondro micro fracture mallet
AMBLER SURGICAL CORP.
Chondro micro fracture mallet
In Commercial Distribution

  • 00190660195564 ()
41-163

  • Surgical mallet
HyProCure (reusable) Instrument Set. The instrument set contains six Trial Sizers (05mm thru 10mm), one Driver and three Guide Wires. For use with the HyProCure Sinus Tarsi Implant system. Indications: HyProCure is a talotarsal stabilization device used in the treatment of talotarsal dislocation and resulting sequela. The implant is designed to stabilize the talus on the tarsal mechanism to prevent excessive anterior, and/or medial, and/or plantarflexion of the talus on the tarsal mechanism, while allowing normal talotarsal joint motion.
Gramedica
HYP-INS-TRAY
In Commercial Distribution

  • M621HYPINSTRAY0 ()
HYP-INS-TRAY

  • Orthopaedic prosthesis implantation positioning instrument, reusable
HyProCure II (reusable) Instrument Tray-Kit. The Instrument kit contains seven Trial Sizers (06mm thru 12mm) one Driver, one Positioning Sleeve and three Guide Wires). For use with the HyProCure II Sinus Tarsi Implants. Indications: The HyProCure II (HYP II and HYP IIs) Implant is an implant stabilization device used in the treatment of hyperpronating instability of the hindfoot. The implant is designed to stabilize the talus to prevent excessive anterior, and/or medial, and/or plantarflexion of the talus, while allowing normal talotarsal joint motion
Gramedica
HYPII-INS-TRAY
In Commercial Distribution

  • M621HYPIIINSTRAY0 ()
HYPII-INS-TRAY

  • Orthopaedic prosthesis implantation positioning instrument, reusable
HyProCure II Driver instrument. For use with the HyProCure II Sinus Tarsi Implant System. Indications: The HyProCure II (HYP II and HYP IIs) Implant is an implant stabilization device used in the treatment of hyperpronating instability of the hindfoot. The implant is designed to stabilize the talus to prevent excessive anterior, and/or medial, and/or plantarflexion of the talus, while allowing normal talotarsal joint motion.
Gramedica
HYP II-5
In Commercial Distribution

  • M621HYPII50 ()

  • Length: 177.80 Millimeter
HYP II-5

  • Orthopaedic prosthesis implantation positioning instrument, reusable
HyProCure Driver. Reusable instrument, for use with the HyProCure Sinus Tarsi Implant System. Indications: HyProCure is a talotarsal stabilization device used in the treatment of talotarsal dislocation and resulting sequela. The implant is designed to stabilize the talus on the tarsal mechanism to prevent excessive anterior, and/or medial, and/or plantarflexion of the talus on the tarsal mechanism, while allowing normal talotarsal joint motion.
Gramedica
HD-5-FG
In Commercial Distribution

  • M621HD5FG0 ()
HD-5-FG

  • Orthopaedic prosthesis implantation positioning instrument, reusable
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