The following data is part of a premarket notification filed by Medtronic Sofamor Danek Usa with the FDA for Telamon Peek Spinal System.
| Device ID | K110562 |
| 510k Number | K110562 |
| Device Name: | TELAMON PEEK SPINAL SYSTEM |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | MEDTRONIC SOFAMOR DANEK USA 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Regina Holmes |
| Correspondent | Regina Holmes MEDTRONIC SOFAMOR DANEK USA 1800 PYRAMID PLACE Memphis, TN 38132 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-02-28 |
| Decision Date | 2011-11-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00673978958408 | K110562 | 000 |
| 00673978929330 | K110562 | 000 |
| 00673978929323 | K110562 | 000 |
| 00673978929293 | K110562 | 000 |
| 00673978929279 | K110562 | 000 |