K122513 is an FDA 510(k) clearance for the CLEARED UNDER GRAFTON II EDBM. This device is classified as a Filler, Bone Void, Osteoinduction (w/o Human Growth Factor) (Class II - Special Controls, product code MBP).
Submitted by Medtronic Sofamor Danek, Inc. (Memphis, US). The FDA issued a Cleared decision on March 6, 2013, 201 days after receiving the submission on August 17, 2012.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3045.
| 510(k) Number | K122513 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 17, 2012 |
| Decision Date | March 06, 2013 |
| Days to Decision | 201 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 |