The following data is part of a premarket notification filed by Synthes Spine with the FDA for Synthes Anterior Cslp System.
Device ID | K000536 |
510k Number | K000536 |
Device Name: | SYNTHES ANTERIOR CSLP SYSTEM |
Classification | Appliance, Fixation, Spinal Intervertebral Body |
Applicant | SYNTHES SPINE P.O. BOX 0548 1690 RUSSELL ROAD Paoli, PA 19301 |
Contact | Jonathan Gilbert |
Correspondent | Jonathan Gilbert SYNTHES SPINE P.O. BOX 0548 1690 RUSSELL ROAD Paoli, PA 19301 |
Product Code | KWQ |
CFR Regulation Number | 888.3060 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-02-16 |
Decision Date | 2000-03-15 |