The following data is part of a premarket notification filed by Medtronic Sofamor Danek with the FDA for Venture Anterior Cervical Plate System.
| Device ID | K061274 |
| 510k Number | K061274 |
| Device Name: | VENTURE ANTERIOR CERVICAL PLATE SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | MEDTRONIC SOFAMOR DANEK 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Richard Trehame |
| Correspondent | Richard Trehame MEDTRONIC SOFAMOR DANEK 1800 PYRAMID PLACE Memphis, TN 38132 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-05-08 |
| Decision Date | 2006-05-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994265050 | K061274 | 000 |
| 00885074529745 | K061274 | 000 |
| 00885074529721 | K061274 | 000 |
| 00885074529707 | K061274 | 000 |
| 00885074529691 | K061274 | 000 |
| 00885074529684 | K061274 | 000 |
| 00885074529660 | K061274 | 000 |
| 00885074529653 | K061274 | 000 |
| 00885074529646 | K061274 | 000 |
| 00885074529639 | K061274 | 000 |
| 00885074529622 | K061274 | 000 |
| 00885074529615 | K061274 | 000 |
| 00885074529752 | K061274 | 000 |
| 00885074529769 | K061274 | 000 |
| 00613994265043 | K061274 | 000 |
| 00613994264954 | K061274 | 000 |
| 00613994264947 | K061274 | 000 |
| 00613994264930 | K061274 | 000 |
| 00613994264923 | K061274 | 000 |
| 00613994264916 | K061274 | 000 |
| 00613994264909 | K061274 | 000 |
| 00613994264893 | K061274 | 000 |
| 00613994264886 | K061274 | 000 |
| 00613994264879 | K061274 | 000 |
| 00613994264862 | K061274 | 000 |
| 00885074529585 | K061274 | 000 |