K130498 is an FDA 510(k) clearance for the OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY. This device is classified as a Filler, Bone Void, Osteoinduction (w/o Human Growth Factor) (Class II - Special Controls, product code MBP).
Submitted by Bacterin International, Inc. (Belgrade, US). The FDA issued a Cleared decision on May 31, 2013, 94 days after receiving the submission on February 26, 2013.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3045.
| 510(k) Number | K130498 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 26, 2013 |
| Decision Date | May 31, 2013 |
| Days to Decision | 94 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | MBP — Filler, Bone Void, Osteoinduction (w/o Human Growth Factor) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3045 |