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
DAS Multi-Unit insertion tool
TALLADIUM ESPAÑA SL
49.409.000.01-2
In Commercial Distribution

  • 08436568733937 ()


  • Surgical torque wrench adaptor
DAS Multi-Unit Screwdriver. L21mm
TALLADIUM ESPAÑA SL
43.321.316.01-2
In Commercial Distribution

  • 08436568733722 ()


  • Surgical screwdriver, reusable
Atlantis Angulated Screw Access Screwdriver L32mm, 30
TALLADIUM ESPAÑA SL
36032
In Commercial Distribution

  • 08436568732534 ()


  • Surgical screwdriver, reusable
Atlantis Angulated Screw Access Screwdriver L18mm, 30
TALLADIUM ESPAÑA SL
36030
In Commercial Distribution

  • 08436568732510 ()


  • Surgical screwdriver, reusable
No Description
CAYENNE MEDICAL, INC.
CM-7120
In Commercial Distribution

  • M543CM7120 ()
CM-7120

  • Manual wire driver
Screwdriver IO adaptor. L24mm
TALLADIUM ESPAÑA SL
43.624.410.01-2
In Commercial Distribution

  • 08436568735702 ()


  • Surgical screwdriver, reusable
Screwdriver IO adaptor. MB, MD. L20mm
TALLADIUM ESPAÑA SL
43.620.411.01-2
In Commercial Distribution

  • 08436568734477 ()


  • Surgical screwdriver, reusable
Atlantis Angulated Screw Access Screwdriver L24mm, 30
TALLADIUM ESPAÑA SL
36031
In Commercial Distribution

  • 08436568732527 ()


  • Surgical screwdriver, reusable
No Description
CAYENNE MEDICAL, INC.
CM-9580
In Commercial Distribution

  • M543CM9580 ()
CM-9580

  • Cannulated surgical drill bit, single-use
No Description
CAYENNE MEDICAL, INC.
CM-9570
In Commercial Distribution

  • M543CM9570 ()
CM-9570

  • Cannulated surgical drill bit, single-use
No Description
CAYENNE MEDICAL, INC.
CM-9560
In Commercial Distribution

  • M543CM9560 ()
CM-9560

  • Cannulated surgical drill bit, single-use
No Description
CAYENNE MEDICAL, INC.
CM-9550
In Commercial Distribution

  • M543CM9550 ()
CM-9550

  • Cannulated surgical drill bit, single-use
No Description
CAYENNE MEDICAL, INC.
CM-9540
In Commercial Distribution

  • M543CM9540 ()
CM-9540

  • Cannulated surgical drill bit, single-use
Final Tightening Driver
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555272000010 ()
27-2000-010

  • Internal spinal fixation procedure kit, reusable
Polyaxial Screw Driver Assembly
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555272000001 ()
27-2000-001

  • Internal spinal fixation procedure kit, reusable
Poly Screw Driver, Short
AMEDICA CORPORATION
D
Not in Commercial Distribution

  • M555211000104 ()
21-1000-104

  • Internal spinal fixation procedure kit, reusable
Cross Connector Screw Driver
AMEDICA CORPORATION
M
Not in Commercial Distribution

  • M555115000010 ()
11-5000-010

  • Internal spinal fixation procedure kit, reusable
Driver, Thick Shaft, Final Tightening
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555114000014 ()
11-4000-014

  • Internal spinal fixation procedure kit, reusable
Final Tightening Driver
AMEDICA CORPORATION
N
Not in Commercial Distribution

  • M555114000010 ()
11-4000-010

  • Internal spinal fixation procedure kit, reusable
Screwdriver Tiny IO adaptor. L21mm
TALLADIUM ESPAÑA SL
43.621.415.01-2
In Commercial Distribution

  • 08436568739656 ()


  • Surgical screwdriver, reusable
Wrench adaptor comp.Straumann
TALLADIUM ESPAÑA SL
49.604.000.07-2
In Commercial Distribution

  • 08436568735856 ()


  • Surgical torque wrench adaptor
Wrench adaptor
TALLADIUM ESPAÑA SL
49.604.000.05-2
In Commercial Distribution

  • 08436568735849 ()


  • Surgical torque wrench adaptor
Screwdriver IO adaptor. L21mm
TALLADIUM ESPAÑA SL
43.621.410.01-2
In Commercial Distribution

  • 08436568735733 ()


  • Surgical screwdriver, reusable
Polyaxial Screw Driver
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555273000001 ()
27-3000-001

  • Internal spinal fixation procedure kit, reusable
5.5mm, Poly Screw Driver
AMEDICA CORPORATION
C
Not in Commercial Distribution

  • M555241000102 ()
24-1000-102

  • Internal spinal fixation procedure kit, reusable
Poly Screw Driver 8.2mm, 5.5mm Rod
AMEDICA CORPORATION
D
Not in Commercial Distribution

  • M555211000103 ()
21-1000-103

  • Internal spinal fixation procedure kit, reusable
Poly Screw Driver - HF
AMEDICA CORPORATION
C
Not in Commercial Distribution

  • M555211000102 ()
21-1000-102

  • Internal spinal fixation procedure kit, reusable
Tool used to thread and unscrew the top of the countersink body for easy disassembly.
ABANZA TECNOMED SL.
21
In Commercial Distribution

  • 08437019739331 ()
  • 28437019739335 ()


  • Surgical screwdriver, reusable
Instrument used to screw the “screw-washer” assembly to the cap, locking the tendon against the locking corridor of the cap.
ABANZA TECNOMED SL.
21
In Commercial Distribution

  • 08437019739164 ()
  • 28437019739168 ()


  • Surgical screwdriver, reusable
Cross Connector Driver - Hex
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555115000067 ()
11-5000-067

  • Internal spinal fixation procedure kit, reusable
Screwdriver Hex1.25
TALLADIUM ESPAÑA SL
43.601.104.01-2
In Commercial Distribution

  • 08436568739892 ()


  • Surgical screwdriver, reusable
Response 5.5/6.0 Pedicle Screw Driver, ZH Drive
ORTHOPEDIATRICS CORP.
01-1300-8335
In Commercial Distribution

  • 00840194418256 ()
01-1300-8335

  • Surgical screwdriver, reusable
Response 5.5/6.0 Pedicle Screw Driver, Square Drive
ORTHOPEDIATRICS CORP.
01-1300-8035
In Commercial Distribution

  • 00840194418249 ()
01-1300-8035

  • Surgical screwdriver, reusable
5.5/6.0 Cannulated Reduction Pedicle Screw Driver, T15, Zimmer Hudson Connect
ORTHOPEDIATRICS CORP.
01-1301-6036
In Commercial Distribution

  • 00840194417877 ()


  • Surgical screwdriver, reusable
5.5/6.0 Cannulated Pedicle Screw Driver, T15, Zimmer Hudson Connect
ORTHOPEDIATRICS CORP.
01-1301-6035
In Commercial Distribution

  • 00840194417013 ()


  • Surgical screwdriver, reusable
10mm Driver, Square Drive
ORTHOPEDIATRICS CORP.
01-2200-0005
In Commercial Distribution

  • 00840194411219 ()
01-2200-0005

  • Surgical torque wrench, reusable
No Description
ORTHOPEDIATRICS CORP.
01-1300-5103
In Commercial Distribution

  • 00840194405645 ()
01-1300-5103

  • Orthopaedic surgical procedure kit, non-medicated, reusable
13mm Opening Reamer
ORTHOPEDIATRICS CORP.
01-1501-0093
In Commercial Distribution

  • 00840194405546 ()
01-1501-0093

  • Medullary canal orthopaedic reamer shaft
12mm Opening Reamer
ORTHOPEDIATRICS CORP.
01-1501-0092
In Commercial Distribution

  • 00840194405539 ()
01-1501-0092

  • Medullary canal orthopaedic reamer shaft
11mm Opening Reamer
ORTHOPEDIATRICS CORP.
01-1501-0091
In Commercial Distribution

  • 00840194405522 ()
01-1501-0091

  • Medullary canal orthopaedic reamer shaft
5.0mm Hex, Non-Retaining, Cannulated Driver, Long
ORTHOPEDIATRICS CORP.
01-1402-0015
In Commercial Distribution

  • 00840194404464 ()
01-1402-0015

  • Surgical screwdriver, reusable
5.0mm Hex, Non-Retaining, Cannulated Driver, Short
ORTHOPEDIATRICS CORP.
01-1402-0011
In Commercial Distribution

  • 00840194404457 ()
01-1402-0011

  • Surgical screwdriver, reusable
Abutment Driver Latch Handpiece 23mm, OverDLock Attachment System
FAICO MEDICAL LLC
LOC50075
Not in Commercial Distribution

  • 00840192718174 ()


  • Dental implant system
Abutment Driver Square Drive Torque Wrench 21mm, OverDLock Attachment System
FAICO MEDICAL LLC
LOC50071
Not in Commercial Distribution

  • 00840192718167 ()


  • Dental implant system
Abutment Driver Square Drive Torque Wrench 15mm, OverDLock Attachment System
FAICO MEDICAL LLC
LOC50070
Not in Commercial Distribution

  • 00840192718150 ()


  • Dental implant system
Ratcheting Screwdriver detachable complete. Cross Head
FAICO MEDICAL LLC
CD-001-00
Not in Commercial Distribution

  • 00840192716552 ()


  • Surgical screwdriver, reusable
Mandibular Reconstruction Plate. Thickness 2.2mm. 6+19+6 L-form. Double. 65 degrees
FAICO MEDICAL LLC
MRP-2.2-6+19+6-LL
Not in Commercial Distribution

  • 00840192714619 ()


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
Mandibular Reconstruction Plate. Thickness 2.2mm. 6+17+6 L-form. Double. 65 degrees
FAICO MEDICAL LLC
MRP-2.2-6+17+6-LL
Not in Commercial Distribution

  • 00840192714602 ()


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
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