The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Mastergraft Putty Bone Void Filler.
| Device ID | K051386 |
| 510k Number | K051386 |
| Device Name: | MASTERGRAFT PUTTY BONE VOID FILLER |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | MEDTRONIC VASCULAR 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Richard Treharne |
| Correspondent | Richard Treharne MEDTRONIC VASCULAR 1800 PYRAMID PLACE Memphis, TN 38132 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-05-27 |
| Decision Date | 2005-12-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169486454 | K051386 | 000 |
| 00643169486447 | K051386 | 000 |
| 00643169486430 | K051386 | 000 |
| 00643169486423 | K051386 | 000 |
| 00643169486416 | K051386 | 000 |