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510(k) Data Aggregation
K Number
K190889Device Name
Republic Spine Restore Cervical Interbody Fusion System
Manufacturer
Republic Spine, L.L.C.
Date Cleared
2019-06-19
(75 days)
Product Code
ODP
Regulation Number
888.3080Why did this record match?
Applicant Name (Manufacturer) :
Republic Spine, L.L.C.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
When used as a cervical intervertebral body fusion device, the Republic Spine Restore Cervical Interbody Fusion System is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the C7-T1 disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.
Device Description
The Republic Spine Restore Cervical Interbody Fusion System will be offered in various device configurations based on surgical approach and patient anatomy, and consist of a Republic Spine Restore cervical interbody fusion device, which is intended to be implanted as a single device via an anterior approach.
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K Number
K181495Device Name
Republic Spine Dark Star Spinal System
Manufacturer
Republic Spine, L.L.C.
Date Cleared
2018-07-25
(49 days)
Product Code
NKB
Regulation Number
888.3070Why did this record match?
Applicant Name (Manufacturer) :
Republic Spine, L.L.C.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Republic Spine Dark Star Spinal System is intended for posterior, non-cervical pedicle rigid fixation of the spine to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine (T1-S1):
- · Degenerative Disc Disease (DDD);
- · Spondylolisthesis;
- · Trauma (i.e. fracture or dislocation);
- · Spinal stenosis;
- · Curvatures (i.e. scoliosis, kyphosis, and/or lordosis);
- · Tumor;
- · Pseudoarthrosis; and
- · Failed previous fusion
Device Description
The Republic Spine Dark Star Spinal System is a multi-component posterior spinal fixation system which consists of pedicle screws, rods, locking spacers, and cross-linking mechanism. The system is contains non-sterile single use titanium alloy (Ti-6AI-4V ELI) implantable components that comply with ASTM F136. Various sizes of these implants are available. Instrumentation is available for the delivery and removal of the Republic Spine Dark Star Spinal System. The system allows the surgeon to build a spinal implant construct to stabilize and promote spinal fusion.
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