The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Cervifix/ Axon.
Device ID | K023675 |
510k Number | K023675 |
Device Name: | SYNTHES CERVIFIX/ AXON |
Classification | Appliance, Fixation, Spinal Interlaminal |
Applicant | SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
Contact | Vikki M Hoffman |
Correspondent | Vikki M Hoffman SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
Product Code | KWP |
CFR Regulation Number | 888.3050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-11-01 |
Decision Date | 2002-11-26 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
H9814989140 | K023675 | 000 |