The following data is part of a premarket notification filed by Medtronic Sofamor Danek with the FDA for Cornerstone Psr Cervical Interbody Fusion Device.
| Device ID | K100214 |
| 510k Number | K100214 |
| Device Name: | CORNERSTONE PSR CERVICAL INTERBODY FUSION DEVICE |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| 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 | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-01-25 |
| Decision Date | 2010-06-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994367495 | K100214 | 000 |
| 00613994366054 | K100214 | 000 |
| 00613994366047 | K100214 | 000 |
| 00613994366030 | K100214 | 000 |
| 00613994366009 | K100214 | 000 |
| 00613994365996 | K100214 | 000 |
| 00613994365989 | K100214 | 000 |
| 00613994365972 | K100214 | 000 |
| 00613994365965 | K100214 | 000 |
| 00613994365958 | K100214 | 000 |
| 00613994365941 | K100214 | 000 |
| 00613994366061 | K100214 | 000 |
| 00613994366078 | K100214 | 000 |
| 00613994367488 | K100214 | 000 |
| 00613994367471 | K100214 | 000 |
| 00613994367464 | K100214 | 000 |
| 00613994367457 | K100214 | 000 |
| 00613994367440 | K100214 | 000 |
| 00613994367433 | K100214 | 000 |
| 00613994367426 | K100214 | 000 |
| 00613994366108 | K100214 | 000 |
| 00613994366092 | K100214 | 000 |
| 00613994366085 | K100214 | 000 |
| 00613994365934 | K100214 | 000 |