The following data is part of a premarket notification filed by Sanacor with the FDA for Active Anterior Cervical Plate System.
| Device ID | K073500 |
| 510k Number | K073500 |
| Device Name: | ACTIVE ANTERIOR CERVICAL PLATE SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | SANACOR 765 EAST 340 SOUTH, SUITE 204 American Fork, UT 84003 |
| Contact | Mike Ensign |
| Correspondent | Mike Ensign SANACOR 765 EAST 340 SOUTH, SUITE 204 American Fork, UT 84003 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-12-13 |
| Decision Date | 2008-07-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B6785210110 | K073500 | 000 |
| B7688210670 | K073500 | 000 |
| B7688210620 | K073500 | 000 |
| B7688210610 | K073500 | 000 |
| B7688210600 | K073500 | 000 |
| B7688210590 | K073500 | 000 |
| B7688210440 | K073500 | 000 |
| B7688210430 | K073500 | 000 |
| B7688210420 | K073500 | 000 |
| B6785210010 | K073500 | 000 |
| B6785210020 | K073500 | 000 |
| B6785210100 | K073500 | 000 |
| B6785210090 | K073500 | 000 |
| B6785210080 | K073500 | 000 |
| B6785210070 | K073500 | 000 |
| B6785210060 | K073500 | 000 |
| B6785210050 | K073500 | 000 |
| B6785210040 | K073500 | 000 |
| B6785210030 | K073500 | 000 |
| B7688210410 | K073500 | 000 |
| B7688210400 | K073500 | 000 |
| B7688210390 | K073500 | 000 |
| B6788210430 | K073500 | 000 |
| B6788210420 | K073500 | 000 |
| B6788210410 | K073500 | 000 |
| B6788210400 | K073500 | 000 |
| B6788210390 | K073500 | 000 |
| B6788210380 | K073500 | 000 |
| B6788210370 | K073500 | 000 |
| B6788210360 | K073500 | 000 |
| B6788210440 | K073500 | 000 |
| B6788210590 | K073500 | 000 |
| B7688210380 | K073500 | 000 |
| B7688210370 | K073500 | 000 |
| B7688210360 | K073500 | 000 |
| B7688210350 | K073500 | 000 |
| B6788210670 | K073500 | 000 |
| B6788210620 | K073500 | 000 |
| B6788210610 | K073500 | 000 |
| B6788210600 | K073500 | 000 |
| B6788210350 | K073500 | 000 |
| B6785210520 | K073500 | 000 |
| B6785210410 | K073500 | 000 |
| B6785210400 | K073500 | 000 |
| B6785210390 | K073500 | 000 |
| B6785210380 | K073500 | 000 |
| B6785210370 | K073500 | 000 |
| B6785210360 | K073500 | 000 |
| B6785210350 | K073500 | 000 |
| B6785210340 | K073500 | 000 |
| B6785210420 | K073500 | 000 |
| B6785210430 | K073500 | 000 |
| B6785210510 | K073500 | 000 |
| B6785210500 | K073500 | 000 |
| B6785210490 | K073500 | 000 |
| B6785210480 | K073500 | 000 |
| B6785210470 | K073500 | 000 |
| B6785210460 | K073500 | 000 |
| B6785210450 | K073500 | 000 |
| B6785210440 | K073500 | 000 |
| B6785210330 | K073500 | 000 |
| B6785210320 | K073500 | 000 |
| B6785210310 | K073500 | 000 |
| B6785210200 | K073500 | 000 |
| B6785210190 | K073500 | 000 |
| B6785210180 | K073500 | 000 |
| B6785210170 | K073500 | 000 |
| B6785210160 | K073500 | 000 |
| B6785210150 | K073500 | 000 |
| B6785210140 | K073500 | 000 |
| B6785210130 | K073500 | 000 |
| B6785210210 | K073500 | 000 |
| B6785210220 | K073500 | 000 |
| B6785210300 | K073500 | 000 |
| B6785210290 | K073500 | 000 |
| B6785210280 | K073500 | 000 |
| B6785210270 | K073500 | 000 |
| B6785210260 | K073500 | 000 |
| B6785210250 | K073500 | 000 |
| B6785210240 | K073500 | 000 |
| B6785210230 | K073500 | 000 |
| B6785210120 | K073500 | 000 |