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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 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, 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
Stainless Steel Facet Locator - Cannulated
Nutech Spine, Inc.
IR
In Commercial Distribution

  • B946NF1001SC0 ()
NF-1001SC

  • External spinal fixation system
Stainless Steel Facet Locator
Nutech Spine, Inc.
IR
In Commercial Distribution

  • B946NF1001S0 ()
NF-1001S

  • External spinal fixation system
Carbon Fiber Facet Locator
Nutech Spine, Inc.
IR
In Commercial Distribution

  • B946NF10010 ()
NF-1001

  • External spinal fixation system
A SINGLE, STERILE CUP THAT ATTACHES TO A PLATFORM (NOT INCLUDED) TO HOLD INSTRUMENTS DURING A SURGICAL PROCEDURE. THIS CUP IS SOLD SINGLY TO ACCOMMODATE HOSPITALS WHO WISH TO BUY IN BULK. HOWEVER TWO CUPS ARE REQUIRED TO BE ATTACHED TO THE PLATFORM WHEN IT IS BEING USED.
JB Medical Development, LLC
14-101-01
In Commercial Distribution

  • B99214101010 ()
1410101

  • Surgical instrument interim-placement holder, single-use
#8 Torx Driver
Leith Medical LLC
9001-0008
In Commercial Distribution

  • B953900100080 ()

  • Length: 3.5 Inch


  • Orthopaedic implant driver
Carbon Fiber Handle
Nutech Spine, Inc.
IR
In Commercial Distribution

  • B946NF10060 ()
NF-1006

  • External spinal fixation system
Facet Sound
Nutech Spine, Inc.
IR
In Commercial Distribution

  • B946NF10040 ()
NF-1004

  • External spinal fixation system
Cervical Final Driver
AMEDICA CORPORATION
A
In Commercial Distribution

  • M555910025005 ()
91.002.5005

  • Internal spinal fixation procedure kit, single-use
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