K230565 is an FDA 510(k) clearance for the HILINE™ Fixation System. This device is classified as a Bone Fixation Cerclage, Sublaminar (Class II - Special Controls, product code OWI).
Submitted by Globus Medical, Inc. (Audubon, US). The FDA issued a Cleared decision on April 20, 2023, 50 days after receiving the submission on March 1, 2023.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3010. 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..
| 510(k) Number | K230565 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 01, 2023 |
| Decision Date | April 20, 2023 |
| Days to Decision | 50 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | OWI — Bone Fixation Cerclage, Sublaminar |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3010 |
| 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. |