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510(k) Data Aggregation
K Number
K132122Device Name
KESTREL POSTERIOR CERVICAL SPINE SYSTEM
Manufacturer
OMNI SURGICAL LLC DBA SPINE360
Date Cleared
2014-01-22
(196 days)
Product Code
KWP
Regulation Number
888.3050Why did this record match?
Applicant Name (Manufacturer) :
OMNI SURGICAL LLC DBA SPINE360
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Kestrel Posterior Cervical Fixation System is intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput - T3). The system is intended for posterior, cervical, non-pedicle fixation, or for posterior, noncervical pedicle fixation 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
- Spondylolisthesis
- Trauma (i.e fracture or dislocation)
- Spinal stenosis, curvatures (i.e. scoliosis, kyphosis, and /or lordosis)
- Tumor
- Pseudoarthrosis
- Failed previous fusion
Occipital bone screws are limited to occipital fixation only. Pedicle bone screws are limited to placement in the upper thoracic spine (TI, T3) when anchoring the OCT construct only. Pedicle screws are not intended to be placed in the cervical spine. Hooks and wires (not pedicle screws) are used to achieve cervical fusion for the occipital/cervical loop
Device Description
The proposed SPINE360 Kestrel system consists of screws, locking caps, rods, cross links, hooks, and instruments.
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