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510(k) Data Aggregation
K Number
K133363Device Name
INTERBRIDGE INTERSPINOUS POSTERIOR FIXATION SYSTEM
Manufacturer
LDR SPINE, USA, INC.
Date Cleared
2014-03-07
(126 days)
Product Code
PEK
Regulation Number
888.3050Why did this record match?
Applicant Name (Manufacturer) :
LDR SPINE, USA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The InterBRIDGE® System is a posterior, non-pedicle supplemental fixation device intended for single-level use only in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions:
- . Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
- Spondylolisthesis .
- Trauma (fracture or dislocation) .
- . Tumor
The InterBRIDGE® system is not intended for stand-alone use.
Device Description
The InterBRIDGE® System is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion.
The system is implanted via a posterior approach to the spine. The InterBRIDGE® System includes various sizes of titanium plate constructs. The implants are provided sterile and single use. The instrumentation is non-sterile and reusable.
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