The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Calcium Sulfate Bone Void Filler Pellets (synthes Pellets).
| Device ID | K002362 |
| 510k Number | K002362 |
| Device Name: | SYNTHES CALCIUM SULFATE BONE VOID FILLER PELLETS (SYNTHES PELLETS) |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli, PA 19301 -1222 |
| Contact | Bonnie J Smith |
| Correspondent | Bonnie J Smith SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli, PA 19301 -1222 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-03 |
| Decision Date | 2000-11-01 |
| Summary: | summary |