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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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Closed Lateral Connector, 3.5 Rod. The Sierra occipito-cervico-thoracic (OCT) spinal fixation system, including polyaxial screws, rods, locking caps, occipital plates, occipital screws, lateral connectors, contoured crossbars, hooks, and components, is used to provide stabilization of the spine in order to permit the biological process of spinal fusion to occur. Accepted standard techniques of spinal fusion are an integral part of the implantation of this system.
Seaspine Orthopedics Corporation
50-0035
In Commercial Distribution

  • 10889981042318 ()

  • 3.5
50-0035

  • Cannulated surgical drill bit, single-use
Le Fort Surgical Guide - Wall with Splints - Resin
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860007543494 ()
GCLPFBC

  • Custom-made orthopaedic/craniofacial surgical guide
Le Fort Surgical Guide - Slots with Splints - Resin
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860007543487 ()
GCLRFBC

  • Custom-made orthopaedic/craniofacial surgical guide
Le Fort Surgical Guide - Wall Resin
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860007543470 ()
GCLPBC

  • Custom-made orthopaedic/craniofacial surgical guide
Le Fort Surgical Guide - Slots Resin
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860007543463 ()
GCLRBC

  • Custom-made orthopaedic/craniofacial surgical guide
Final Orthognathic Surgical Splint
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860007543456 ()
FFCOBC

  • Custom-made orthopaedic/craniofacial surgical guide
Intermediate Orhognathic Surgical Splint
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860007543449 ()
FICOBC

  • Custom-made orthopaedic/craniofacial surgical guide
2.0 - 3.2 Pin Driver Assembly
Insurgical, Inc.
320-0070-001
In Commercial Distribution

  • 00860007230066 ()
9250022

  • Pin-driving power tool attachment
3.2 - 4.0 Pin Driver Assembly
Insurgical, Inc.
320-0107-001
In Commercial Distribution

  • 00860007230059 ()
9250023

  • Pin-driving power tool attachment
The MIS Precision Chevron Bunion System™ is a kit designed to allow surgeons to perform a chevron bunion osteotomy, and subsequent fixation of the osteotomy, with a minimally invasive surgical technique. The MIS Precision Chevron Bunion System™ consists of a single, sterile-packaged SKU that contains both implants and instruments needed for the procedure. The implants in the kit are cannulated headless compression screws, made from titanium (Ti-6AL-4V ELI). There are two implants in the kit, however only one is used in a surgical procedure. Two implants are provided to allow the physician to select the proper size for the patient at the time of surgery. The implants are 3.5 mm diameter, with lengths of 24 mm and 27 mm. There are also single-use instruments, made of injection molded polycarbonate, PEEK, and stainless steel included in the MIS Precision Chevron Bunion System™. Instruments include an osteotomy guide (one each for left and right feet), a targeting guide, a screw guide, screwdriver, drill bit, and several K-wires and a guidewire. Additional general surgical instrumentation is utilized, but not part of the RELJA system, such as sagittal saw, drivers, and scalpel.
Relja Innovations LLC
RI-2427-C
In Commercial Distribution

  • 00860005968800 ()


  • Orthopaedic bone screw, non-bioabsorbable, sterile
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