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510(k) Data Aggregation
K Number
K192915Device Name
GMA 2.0 Pedicle Screw System
Manufacturer
Date Cleared
2019-11-13
(29 days)
Product Code
Regulation Number
888.3070Why did this record match?
Applicant Name (Manufacturer) :
Grafton Medical Alliance
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The GMA 2.0 Pedicle Screw System is intended for immobilization of the spine. The GMA 2.0 Pedicle Screw System is indicated for posterior, noncervical pedicle fixation as an adjunct to fusion in skeletally mature patients using autograft and/or allograft for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
Device Description
The GMA 2.0 Pedicle Screw System is comprised of pre-bent rods, pedicle screw assemblies with dual lead non-cannulated screws, and a set screw. Various forms and sizes of these implants are available to account for the unique anatomy of individual patients. Components are made of Ti6A14V ELI conforming to ASTM F136. The system includes a set of instruments to aid in the implantation of the device. The instruments are made of medical grade stainless steel per ASTM F899.
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