The following data is part of a premarket notification filed by Theken Spine Llc with the FDA for Modification To Theken Atoll Cervico-thoracic System.
| Device ID | K080790 |
| 510k Number | K080790 |
| Device Name: | MODIFICATION TO THEKEN ATOLL CERVICO-THORACIC SYSTEM |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | THEKEN SPINE LLC 1800 TRIPLETT BLVD. Akron, OH 44306 |
| Contact | Dale Davison |
| Correspondent | Dale Davison THEKEN SPINE LLC 1800 TRIPLETT BLVD. Akron, OH 44306 |
| Product Code | KWP |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-20 |
| Decision Date | 2008-04-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10889981143077 | K080790 | 000 |
| 10889981033767 | K080790 | 000 |
| 10889981033750 | K080790 | 000 |
| 10889981033743 | K080790 | 000 |
| 10889981033736 | K080790 | 000 |
| 10889981033729 | K080790 | 000 |
| 10889981033712 | K080790 | 000 |
| 10889981033705 | K080790 | 000 |
| 10889981033699 | K080790 | 000 |
| 10889981033682 | K080790 | 000 |
| 10889981033675 | K080790 | 000 |
| 10889981033774 | K080790 | 000 |
| 10889981033781 | K080790 | 000 |
| 10889981033798 | K080790 | 000 |
| 10889981033897 | K080790 | 000 |
| 10889981033880 | K080790 | 000 |
| 10889981033873 | K080790 | 000 |
| 10889981033866 | K080790 | 000 |
| 10889981033859 | K080790 | 000 |
| 10889981033842 | K080790 | 000 |
| 10889981033835 | K080790 | 000 |
| 10889981033828 | K080790 | 000 |
| 10889981033811 | K080790 | 000 |
| 10889981033804 | K080790 | 000 |
| 10889981033668 | K080790 | 000 |