K200290 is an FDA 510(k) clearance for the Resorbable Mesh Pouch (Ballast MT, OsteoBallast MT). This device is classified as a Filler, Bone Void, Calcium Compound (Class II - Special Controls, product code MQV).
Submitted by SeaSpine Orthopedics Corporation (Irvine, US). The FDA issued a Cleared decision on May 11, 2020, 96 days after receiving the submission on February 5, 2020.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3045.
| 510(k) Number | K200290 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 05, 2020 |
| Decision Date | May 11, 2020 |
| Days to Decision | 96 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | MQV — Filler, Bone Void, Calcium Compound |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3045 |