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510(k) Data Aggregation
K Number
K061943Device Name
ANATOMICA POSTERIOR CERVICAL FIXATION SYSTEM
Manufacturer
ANATOMICA AB
Date Cleared
2007-05-25
(319 days)
Product Code
KWP, MNI
Regulation Number
888.3050Why did this record match?
Applicant Name (Manufacturer) :
ANATOMICA AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Anatomica 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; and
- . failed previous fusion.
Occipital bone screws are limited to occipital fixation only. Pedicle bone screws are limited to placement in the upper thoracic spine (T1, T3) when treating thoracic conditions 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 Anatomica Cervical System is a titanium spinal fixation system for occipito-cervico-thoracic (OCT) fixation that contains screws, hooks, and wires that are assembled to rods using one of several types of connectors (expansion loop, compression loop, ME connector, lateral connector, cable lock connector). The occiput screws are for use in the occiput. The wires are for use in the cervical spine. The screws are for use in the thoracic spine (T1-T3). The hooks are for use in the cervical spine.
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