The following data is part of a premarket notification filed by Theken Spine Llc with the FDA for Theken Coral Spinal System.
| Device ID | K091266 |
| 510k Number | K091266 |
| Device Name: | THEKEN CORAL SPINAL SYSTEM |
| Classification | Thoracolumbosacral Pedicle Screw System |
| 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 | NKB |
| Subsequent Product Code | KWP |
| Subsequent Product Code | KWQ |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-30 |
| Decision Date | 2009-06-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10889981121181 | K091266 | 000 |
| 10889981027988 | K091266 | 000 |
| 10889981027995 | K091266 | 000 |
| 10889981028008 | K091266 | 000 |
| 10889981028015 | K091266 | 000 |
| 10889981028022 | K091266 | 000 |
| 10889981110239 | K091266 | 000 |
| 10889981110253 | K091266 | 000 |
| 10889981110260 | K091266 | 000 |
| 10889981027971 | K091266 | 000 |