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 |