The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Anterior Cervical Locking Plate (aclp) System.
| Device ID | K031276 |
| 510k Number | K031276 |
| Device Name: | SYNTHES ANTERIOR CERVICAL LOCKING PLATE (ACLP) SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
| Contact | Jon Gilbert |
| Correspondent | Jon Gilbert SYNTHES (USA) 1690 RUSSELL RD. 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 | 2003-04-22 |
| Decision Date | 2003-07-02 |
| Summary: | summary |