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U.S. Department of Health and Human Services

Product Classification

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Device bone fixation cerclage, sublaminar
Regulation Description Bone fixation cerclage.
Definition Acts as a bone anchor for temporary stabilization, or used in conjunction with other medical implants of similar metals when wiring is needed, during development of a spinal fusion.
Physical State metallic wire, polyester bands
Technical Method Wrapped around a portion of the sublaminar, posterior spine for temporary stabilization during spinal fusion procedures. May be used in conjunction with other medical implants made of similar metals whenever wiring" may help secure the attachment of other implants.
Target Area sublaminar, posterior spine
Regulation Medical Specialty Orthopedic
Review Panel Orthopedic
Product CodeOWI
Premarket Review Orthopedic Devices (OHT6)
Spinal Devices (DHT6B)
Submission Type 510(k)
Regulation Number 888.3010
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Recognized Consensus Standard
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible