The following data is part of a premarket notification filed by Theken Spine Llc with the FDA for Modification To Coral Spinal System.
| Device ID | K081414 |
| 510k Number | K081414 |
| Device Name: | MODIFICATION TO 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 | 2008-05-20 |
| Decision Date | 2008-06-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10889981030292 | K081414 | 000 |
| 10889981030186 | K081414 | 000 |
| 10889981030193 | K081414 | 000 |
| 10889981030209 | K081414 | 000 |
| 10889981030216 | K081414 | 000 |
| 10889981030223 | K081414 | 000 |
| 10889981030230 | K081414 | 000 |
| 10889981030247 | K081414 | 000 |
| 10889981030254 | K081414 | 000 |
| 10889981030261 | K081414 | 000 |
| 10889981030278 | K081414 | 000 |
| 10889981030285 | K081414 | 000 |
| 10889981030179 | K081414 | 000 |