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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
MIS T27 Screw Adjuster, 1/4"
ALPHATEC SPINE, INC.
17900
In Commercial Distribution

  • 00190376473475 ()


  • Surgical screwdriver, reusable
Head Adjuster, Closed
ALPHATEC SPINE, INC.
17832
In Commercial Distribution

  • 00190376473352 ()


  • Surgical screwdriver, reusable
T27 Screw Adjuster, 1/4"
ALPHATEC SPINE, INC.
17800
In Commercial Distribution

  • 00190376473338 ()


  • Surgical screwdriver, reusable
Reduction T27 Polyaxial Screwdriver, Locking
ALPHATEC SPINE, INC.
17851-225
In Commercial Distribution

  • 00190376473291 ()


  • Surgical screwdriver, reusable
T27 Polyaxial Screwdriver, Locking, Long
ALPHATEC SPINE, INC.
17850-250
In Commercial Distribution

  • 00190376473277 ()


  • Surgical screwdriver, reusable
T27 Polyaxial Screwdriver, Locking, Short
ALPHATEC SPINE, INC.
17850-175
In Commercial Distribution

  • 00190376473253 ()


  • Surgical screwdriver, reusable
ACCESS SCREWDRIVER
ALPHATEC SPINE, INC.
350-150
In Commercial Distribution

  • 00190376471525 ()


  • Surgical screwdriver, reusable
DRIVER A22020200 NUT DRIVER
MEDICREA INTERNATIONAL
A22020200
In Commercial Distribution

  • 03613720293644 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
OFFSET NUT DRIVER FOR PASS LP
MEDICREA INTERNATIONAL
A99180700
Not in Commercial Distribution

  • 03613720274674 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Driver for Pins
SPINEVISION
AC2-A216
In Commercial Distribution

  • 03663136001142 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
NUT DRIVER T25
MEDICREA INTERNATIONAL
A22020210
Not in Commercial Distribution

  • 03613720264996 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
NUT DRIVER
MEDICREA INTERNATIONAL
A22020200
In Commercial Distribution

  • 03613720249740 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
CLAW HOOK POST DRIVER
MEDICREA INTERNATIONAL
A19040440
Not in Commercial Distribution

  • 03613720247173 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
NUT DRIVER
MEDICREA INTERNATIONAL
A19030110
Not in Commercial Distribution

  • 03613720247098 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Head Adjuster, Wide Offset R
ALPHATEC SPINE, INC.
17824-R
In Commercial Distribution

  • 00190376483191 ()


  • Surgical screwdriver, reusable
AMP-LTX Blocker Driver
ALPHATEC SPINE, INC.
610-340
In Commercial Distribution

  • 00190376478005 ()


  • Surgical screwdriver, reusable
Plate Final Driver
ALPHATEC SPINE, INC.
610-330
In Commercial Distribution

  • 00190376477992 ()


  • Surgical screwdriver, reusable
Bone Screwdriver, Ball Hex
ALPHATEC SPINE, INC.
610-320
In Commercial Distribution

  • 00190376477985 ()


  • Surgical screwdriver, reusable
Bone Screwdriver, Active
ALPHATEC SPINE, INC.
610-310
In Commercial Distribution

  • 00190376477978 ()


  • Surgical screwdriver, reusable
Bone Screwdriver, Stab n Grab Offset
ALPHATEC SPINE, INC.
610-301
In Commercial Distribution

  • 00190376477961 ()


  • Surgical screwdriver, reusable
Bone Screwdriver, Stab n Grab
ALPHATEC SPINE, INC.
610-300
In Commercial Distribution

  • 00190376477954 ()


  • Surgical screwdriver, reusable
Head Adjuster, Wide Offset L
ALPHATEC SPINE, INC.
17824-L
In Commercial Distribution

  • 00190376477176 ()


  • Surgical screwdriver, reusable
MIS Reduction T27 Polyaxial Screwdriver, Locking, Navigation
ALPHATEC SPINE, INC.
17951-N
In Commercial Distribution

  • 00190376475219 ()


  • Surgical screwdriver, reusable
MIS T27 Polyaxial Screwdriver, Locking, Navigation
ALPHATEC SPINE, INC.
17950-N
In Commercial Distribution

  • 00190376475202 ()


  • Surgical screwdriver, reusable
Reduction T27 Polyaxial Screwdriver, Locking, Navigation
ALPHATEC SPINE, INC.
17851-N
In Commercial Distribution

  • 00190376475196 ()


  • Surgical screwdriver, reusable
T27 Polyaxial Screwdriver, Locking, Navigation
ALPHATEC SPINE, INC.
17850-N
In Commercial Distribution

  • 00190376475189 ()


  • Surgical screwdriver, reusable
LTX EXPANSION DRIVER AXIAL, 26 in-lbs
ALPHATEC SPINE, INC.
258-510-26
In Commercial Distribution

  • 00190376474779 ()


  • Surgical instrument handle, torque-limiting
LTX EXPANSION DRIVER T-HANDLE, 26 in-lbs
ALPHATEC SPINE, INC.
258-500-26
In Commercial Distribution

  • 00190376474762 ()


  • Surgical instrument handle, torque-limiting
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