K222220 is an FDA 510(k) clearance for the SpinMedix Absorbable Fibrous Membrane. This device is classified as a Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon (Class II - Special Controls, product code OWW).
Submitted by Celestray Biotech Company, LLC., (Bethesda, US). The FDA issued a Cleared decision on July 6, 2023, 346 days after receiving the submission on July 25, 2022.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 878.3300. For Reinforcement Of Soft Tissue Where Weakness Exists During Tendon Repair Procedures..
| 510(k) Number | K222220 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 25, 2022 |
| Decision Date | July 06, 2023 |
| Days to Decision | 346 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | OWW - Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.3300 |
| Definition | For Reinforcement Of Soft Tissue Where Weakness Exists During Tendon Repair Procedures. |