501(K) Spinal Device Approvals

Congratulations to companies who received 510(K) approval this November. Modern Grinding is going to try and list smaller companies who receive approval for spine devices on a monthly basis as a means to provide a view into the newest and latest products on the market:

Product: SPECTRUM SPINE SPINOUS PROCESS DEVICE
Company: SPECTRUM SPINE
Company/Product Description: If you have neck or back pain, you’ve come to the right place. Our Physical Therapists are experts in diagnosing and rehabilitating spinal injuries. We specialize in pre and post surgical rehabilitation, neck and back injuries, and chronic pain.

Product: INTEGRITY SPINE CORE SYSTEM
Company: Integrity Spine
Company/Product Description: Integrity Spine is a medical device company focused on advancing the products and technologies used in spinal procedures.

Product: INTEGRA FACET FIXATION SYSTEM
Company: Seaspine, Inc.
Company/Product Description:

Integra LifeSciences, a world leader in medical technology, is dedicated to limiting uncertainty for surgeons, so they can concentrate on providing the best patient care. Integra offers innovative solutions in orthopedic extremity surgery, neurosurgery, spine surgery, and reconstructive and general surgery.

Integra’s orthopedic products include devices and implants for spine, foot and ankle, hand and wrist, shoulder and elbow, tendon and peripheral nerve protection and repair, and wound repair. Integra is a leader in neurosurgery, offering a broad portfolio of implants, devices, instruments and systems used in neurosurgery, neuromonitoring, neurotrauma, and related critical care. In the United States, Integra is a leading provider of surgical instruments to hospitals, surgery centers and alternate care sites, including physician and dental offices.

Product: APEX SPINE SYSTEM
Company: SPINECRAFT LLC
Company/Product Description: The APEX Spine System is comprised of implants and instruments for stabilization of the spine during fusion in the thoracic, lumbar and sacral regions.

Product: SPINEFRONTIER LESPLASTY POSTERIOR CERVICAL LAMINOPLASTY SYSTEM
Company: SPINEFRONTIER, INC.
Company/Product Description: We combine the experience of surgeons with the ingenuity of engineers to design and develop devices and instruments for spinal fusion and less exposure surgery (LES). Our founding surgeons are involved in every step of the product development cycle, collaborating with our innovation team to create intelligent solutions.

Product: ZIP MIS INTERSPINOUS FUSION SYSTEM
Company: AURORA SPINE
Company/Product Description: The ZIP features articulating bone anchors, a one-step locking mechanism with no set screw and a large graft space designed for biologic material. It is designed for stabilization during T1-S1 lumbar fusion procedures, specifically for the treatment of degenerative disc disease, spondylolisthesis, spinal tumors and trauma. The ZIP is available in various sizes to accommodate different patient anatomy.

Product: ESPIN SYSTEM
Company: NLT SPINE LTD
Company/Product Description: NLT SPINE specializes in the development of innovative spine surgery instrumentation and implants for treating degenerative spinal conditions through small surgical incisions. The company’s vision is to improve patient care and reduce total treatment costs by ultimately shifting from traditional open surgical routines to MISS, employing new methods and technologies to enhance usability and outcomes.

Led by top international leaders in spinal surgery, NLT SPINE holds a wide portfolio of pending and issued patents that cover the non-linear core technology and related implant and instrument technologies.

Product: PASS LP SPINAL SYSTEM
Company: MEDICREA INTERNATIONAL
Company/Product Description: Marketed for the treatment of spinal pathologies (scoliosis, spondylolythesis, traum..) , the PASS LP® thoraco-lumbar fixation system allows to connect the rod at distance from the spine and to perform a 3D correction through progressive stress distribution on all anchorages thanks to the ST2R technique (Simultaneous Translation on 2 Rods).

Product: ANAX 5.5 SPINAL SYSTEM
Company: U & I CORPORATION
Company/Product Description:  The ANAX 5.5 Spinal System is a top-loading multiple component, posterior spinal fixation system which consist of pedicle screws, rods, set screws, connectors, and a transverse (cross) linking mechanism. The ANAX 5.5 Spinal System allows surgeons to build a spinal implant construct to stabilize and promote spinal fusion.

– Top loading for easy introduction of 5.5 mm diameter rod
– A low-profile polyaxial screw head
– Rounded screw head allowing up to 65degrees of angulation
– Double-lead threaded screw for its fast insertion
– No complication but efficiency self tap of the screw
– No cross threading of the set screw
– Rod available in titanium and cobalt chromium (CoCr)

Product: TIGER OCCIPITAL-CERVICAL-THORACIC SPINAL FIXATION SYSTEM
Company: CORELINK LLC
Company/Product Description:  CoreLink designs and manufactures precision surgical instruments and implants with a single goal: to deliver the highest quality products to enable surgeons to provide the best possible outcomes.