510(k) K162639

Clearance Details

Decision

SESE (Substantially Equivalent)

Decision Date

February 7, 2017

Date Received

September 22, 2016

Clearance Type

Traditional

Expedited Review

No

Third Party Review

No

Device Classification

Device Name

Posterior Cervical Screw System

Device Class

Class II

Regulation Number

888.3075

Review Panel

OR

Submission Type

Posterior cervical screw systems are intended for use in fusion procedures of the cervical spine and/or craniocervical junction and/or cervicothoracic junction for: 1) spinal fractures and dislocations; 2) deformities; 3) instabilities; 4) failed previous fusions; 5) tumors; 6) inflammatory disorders; 7) spinal degeneration, 8) facet degeneration with instability; and 9) reconstruction following decompression to treat radiculopathy and/or myelopathy. These systems are also intended to stabilize the spine in the absence of fusion for a limited time period in patients with tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.