The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Button Plate.
Device ID | K994364 |
510k Number | K994364 |
Device Name: | SYNTHES BUTTON PLATE |
Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
Applicant | SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
Contact | Sheri L Musgnung |
Correspondent | Sheri L Musgnung SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
Product Code | MBI |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-12-27 |
Decision Date | 2000-03-15 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
H6794828230 | K994364 | 000 |