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510(k) Data Aggregation
K Number
K101363Device Name
VU CPOD INTERVERTEBRAL BODU FUSION DEVICE
Manufacturer
MUSCULOSKELETAL CLINICAL REGULATORY ADVISERS
Date Cleared
2010-12-16
(216 days)
Product Code
ODP
Regulation Number
888.3080Why did this record match?
Applicant Name (Manufacturer) :
MUSCULOSKELETAL CLINICAL REGULATORY ADVISERS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Vu c POD Intervertebral Body Fusion Device is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical degenerative disc disease (DDD) at one level from C2-C3 to C7-T1. Cervical degenerative disc disease is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history of radiographic studies. The Vu c·POD implants are to be used with autogenous bone graft and implanted via an open, anterior approach. The cervical device is to be used in patients who have had six weeks of nonoperative treatment. The Vu c POD Intervertebral Body Fusion Device is intended for use with supplemental internal fixation systems, such as the Theken Manta Ray or the Theken Tether systems.
Device Description
The Vu c POD Intervertebral Body Fusion Device consists of cervical spinal interbody fusion devices as well as instrumentation designed specifically for the implantation of these devices. The Vu c POD spacers are manufactured from PEEK OPTIMA LT1 polymer per ASTM F2026. Radiographic markers present with the Vu aPOD spacers are comprised of tantalum per ASTM F560. The Vu c POD Intervertebral Body Fusion Device is for single level anterior spinal use from the C2-C3 to C7-T1 disc levels.
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