The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Norian Srs Bone Void Filler.
Device ID | K011897 |
510k Number | K011897 |
Device Name: | NORIAN SRS BONE VOID FILLER |
Classification | Filler, Bone Void, Calcium Compound |
Applicant | SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
Contact | Angela J Silvestri |
Correspondent | Angela J Silvestri SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
Product Code | MQV |
CFR Regulation Number | 888.3045 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-06-18 |
Decision Date | 2001-12-20 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
H679MXRUS20000 | K011897 | 000 |