The following data is part of a premarket notification filed by Theken Spine Llc with the FDA for Bodyform Thoracic Fixation System.
| Device ID | K072407 |
| 510k Number | K072407 |
| Device Name: | BODYFORM THORACIC FIXATION SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | THEKEN SPINE LLC 283 E WATERLOO RD. Akron, OH 44319 |
| Contact | Dale Davison |
| Correspondent | Dale Davison THEKEN SPINE LLC 283 E WATERLOO RD. Akron, OH 44319 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-08-27 |
| Decision Date | 2007-12-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10889981057923 | K072407 | 000 |
| 10889981057770 | K072407 | 000 |
| 10889981057763 | K072407 | 000 |
| 10889981057756 | K072407 | 000 |
| 10889981057749 | K072407 | 000 |
| 10889981057732 | K072407 | 000 |
| 10889981057725 | K072407 | 000 |
| 10889981057718 | K072407 | 000 |
| 10889981057701 | K072407 | 000 |
| 10889981057695 | K072407 | 000 |
| 10889981057688 | K072407 | 000 |
| 10889981057671 | K072407 | 000 |
| 10889981057664 | K072407 | 000 |
| 10889981057787 | K072407 | 000 |
| 10889981057794 | K072407 | 000 |
| 10889981057916 | K072407 | 000 |
| 10889981057909 | K072407 | 000 |
| 10889981057893 | K072407 | 000 |
| 10889981057886 | K072407 | 000 |
| 10889981057879 | K072407 | 000 |
| 10889981057862 | K072407 | 000 |
| 10889981057855 | K072407 | 000 |
| 10889981057848 | K072407 | 000 |
| 10889981057831 | K072407 | 000 |
| 10889981057824 | K072407 | 000 |
| 10889981057817 | K072407 | 000 |
| 10889981057800 | K072407 | 000 |
| 10889981057657 | K072407 | 000 |