The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Spine Small Stature Anterior Cervical Vertebrae Plate System.
Device ID | K971883 |
510k Number | K971883 |
Device Name: | SYNTHES SPINE SMALL STATURE ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEM |
Classification | Appliance, Fixation, Spinal Intervertebral Body |
Applicant | SYNTHES (USA) P.O. BOX 0548 1690 RUSSELL ROAD Paoli, PA 19301 |
Contact | Barry E Sands |
Correspondent | Barry E Sands SYNTHES (USA) P.O. BOX 0548 1690 RUSSELL ROAD Paoli, PA 19301 |
Product Code | KWQ |
CFR Regulation Number | 888.3060 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-05-22 |
Decision Date | 1997-10-16 |
Summary: | summary |