The following data is part of a premarket notification filed by Codman & Shurtleff, Inc. with the FDA for Codman Anterior Cervical Spine Plate System.
| Device ID | K934756 |
| 510k Number | K934756 |
| Device Name: | CODMAN ANTERIOR CERVICAL SPINE PLATE SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | Codman & Shurtleff, Inc. 41 PACELLA PARK DR. RANDOLPH INDUSTRIAL PARK Randolph, MA 02368 -1794 |
| Contact | Amy L Walters |
| Correspondent | Amy L Walters Codman & Shurtleff, Inc. 41 PACELLA PARK DR. RANDOLPH INDUSTRIAL PARK Randolph, MA 02368 -1794 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-10-05 |
| Decision Date | 1994-11-08 |