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 |