The following data is part of a premarket notification filed by Theken Spine Llc with the FDA for Theken Atoll Cervico-thoracic System.
| Device ID | K083073 |
| 510k Number | K083073 |
| Device Name: | THEKEN ATOLL CERVICO-THORACIC SYSTEM |
| Classification | Orthosis, Spinal Pedicle Fixation |
| 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 | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-10-15 |
| Decision Date | 2009-03-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10889981033934 | K083073 | 000 |
| 10889981033927 | K083073 | 000 |
| 10889981033910 | K083073 | 000 |
| 10889981033903 | K083073 | 000 |