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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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HyProCure Instrument Set - M621HYPINSTRAY0

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 Instrument Tray-Set - M621HYPIIINSTRAY0

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 - M621HYPII50

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 - M621HD5FG0

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

osteo-WEDGE Driver - M621GM150030

osteo-WEDGE Driver, a reusable instrument, for use with the osteo-WEDGE Opening Wedge Bone Locking Plate System. The osteo-WEDGE Opening Wedge Bone Locking Plate System is used for adult and transitional adolescent (18 to 21 years old) patients for the purpose of stabilization and/or correction of angular deviations within an individual bone or in between two adjacent bones in the foot, such as opening wedge osteotomy for first metatarsal cuneiform joint deviations.
Gramedica
GM-150-03
In Commercial Distribution

  • M621GM150030 ()

  • Length: 6.89 Inches (175.0mm)
GM-150-03

  • Orthopaedic fixation plate, non-bioabsorbable

Glenojet™ - M528GS0920000

Hex Driver 2.5mm
ARTHROSURFACE INCORPORATED
GS09-2000
In Commercial Distribution

  • M528GS0920000 ()
GS09-2000

  • Joint prosthesis implantation kit, single-use

AlignMate - M5289B0920000

Driver Kit, AlignMATE
ARTHROSURFACE INCORPORATED
9B09-2000
In Commercial Distribution

  • M5289B0920000 ()
9B09-2000

  • Joint prosthesis implantation kit, single-use

PINIT PLATE® - M5289A0940000

Driver, Screw, Minuteman
ARTHROSURFACE INCORPORATED
9A09-4000
In Commercial Distribution

  • M5289A0940000 ()
9A09-4000

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile

ENDOSKELETON® TAS - M682230013140

Fixed Angle Driver Ancillary Handle
TITAN SPINE, LLC
2300-1314
Not in Commercial Distribution

  • M682230013140 ()
2300-1314

  • Orthopaedic inorganic implant inserter/extractor, reusable

ENDOSKELETON TA - M682210610020

SLAP HAMMER
TITAN SPINE, LLC
2106-1002
Not in Commercial Distribution

  • M682210610020 ()

  • Length: 10 Inch
2106-1002

  • Surgical mallet
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