The following data is part of a premarket notification filed by Terray Manufacturing, Inc. with the FDA for Anterior Spinal Fixation Plate.
| Device ID | K870085 |
| 510k Number | K870085 |
| Device Name: | ANTERIOR SPINAL FIXATION PLATE |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | TERRAY MANUFACTURING, INC. 24 MCGONIGAL ST. WEST ARNPRIOR Ontario K7s 1l8, CA |
| Contact | Ray Desjardins |
| Correspondent | Ray Desjardins TERRAY MANUFACTURING, INC. 24 MCGONIGAL ST. WEST ARNPRIOR Ontario K7s 1l8, CA |
| Product Code | KWP |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-01-08 |
| Decision Date | 1987-06-30 |