The following data is part of a premarket notification filed by Medtronic Sofamor Danek, Inc. with the FDA for Cleared Under Grafton Ii Edbm.
| Device ID | K122513 |
| 510k Number | K122513 |
| Device Name: | CLEARED UNDER GRAFTON II EDBM |
| Classification | Filler, Bone Void, Osteoinduction (w/o Human Growth Factor) |
| Applicant | MEDTRONIC SOFAMOR DANEK, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Kelly Anglin |
| Correspondent | Kelly Anglin MEDTRONIC SOFAMOR DANEK, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Product Code | MBP |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-17 |
| Decision Date | 2013-03-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169216242 | K122513 | 000 |
| 00643169216235 | K122513 | 000 |