K212135 is an FDA 510(k) clearance for the Dry DBM- A Putty. This device is classified as a Filler, Bone Void, Calcium Compound (Class II - Special Controls, product code MQV).
Submitted by Seaspine Corporation (Irvine, US). The FDA issued a Cleared decision on October 4, 2021, 88 days after receiving the submission on July 8, 2021.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3045.
| 510(k) Number | K212135 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 08, 2021 |
| Decision Date | October 04, 2021 |
| Days to Decision | 88 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 |