The following data is part of a premarket notification filed by Medtronic Sofamor Danek with the FDA for Intrepid Spinal System.
| Device ID | K080083 |
| 510k Number | K080083 |
| Device Name: | INTREPID SPINAL SYSTEM |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | MEDTRONIC SOFAMOR DANEK 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Lee Grant |
| Correspondent | Lee Grant MEDTRONIC SOFAMOR DANEK 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 | 2008-01-11 |
| Decision Date | 2008-04-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994513489 | K080083 | 000 |
| 00613994504173 | K080083 | 000 |
| 00613994504180 | K080083 | 000 |
| 00613994504197 | K080083 | 000 |
| 00613994504203 | K080083 | 000 |
| 00613994504210 | K080083 | 000 |
| 00613994504227 | K080083 | 000 |
| 00613994504234 | K080083 | 000 |
| 00613994513458 | K080083 | 000 |
| 00613994513472 | K080083 | 000 |
| 00613994504166 | K080083 | 000 |