The following data is part of a premarket notification filed by Medtronic Sofamor Danek Usa, Inc. with the FDA for Medtronic Sofamor Danek Biphasic Calcium Phosphate (bcp) Bone Void Filler.
| Device ID | K010701 |
| 510k Number | K010701 |
| Device Name: | MEDTRONIC SOFAMOR DANEK BIPHASIC CALCIUM PHOSPHATE (BCP) BONE VOID FILLER |
| Classification | Bone Grafting Material, Synthetic |
| Applicant | MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Rihcard W Treharne |
| Correspondent | Rihcard W Treharne MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Product Code | LYC |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-03-08 |
| Decision Date | 2001-06-05 |