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U.S. Department of Health and Human Services

Product Classification

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Device screw sleeve bone fixation device, spine
Regulation Description Screw sleeve bone fixation device.
Definition A spinal screw sleeve bone fixation device is intended to be implanted in conjunction with a non-resorbable, metallic bone screw where the screw has lost purchase due to loosening, backout, or breakage. The device fits between the screw threads and surrounding bone, and provides increased surface area to create an interference fit to restore stability of the implant construct.
Physical State The device is a woven or braided non-resorbable polymer such as polyethylene terephthalate (PET).
Technical Method The device provides augmentation by interdigitating and mechanically wedging between the spinal screw threads and bone.
Target Area For use with spinal screws.
Regulation Medical Specialty Orthopedic
Review Panel Orthopedic
Product CodeQVI
Premarket Review Office of Orthopedic Devices (OHT6)
Spinal Devices (DHT6B)
Submission Type 510(k)
Regulation Number 888.3043
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible