The following data is part of a premarket notification filed by Medtronic Sofamor Danek with the FDA for Modification To Vertex Reconstruction System.
| Device ID | K070742 |
| 510k Number | K070742 |
| Device Name: | MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| 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 | KWP |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-03-16 |
| Decision Date | 2007-09-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994994684 | K070742 | 000 |
| 00613994994806 | K070742 | 000 |
| 00613994994813 | K070742 | 000 |
| 00613994994820 | K070742 | 000 |
| 00613994994837 | K070742 | 000 |
| 00613994994844 | K070742 | 000 |
| 00613994203786 | K070742 | 000 |
| 00613994203823 | K070742 | 000 |
| 00613994203830 | K070742 | 000 |
| 00613994994790 | K070742 | 000 |
| 00613994994783 | K070742 | 000 |
| 00613994994776 | K070742 | 000 |
| 00613994994691 | K070742 | 000 |
| 00613994994707 | K070742 | 000 |
| 00613994994714 | K070742 | 000 |
| 00613994994721 | K070742 | 000 |
| 00613994994738 | K070742 | 000 |
| 00613994994745 | K070742 | 000 |
| 00613994994752 | K070742 | 000 |
| 00613994994769 | K070742 | 000 |
| 00613994203847 | K070742 | 000 |
| 00613994203892 | K070742 | 000 |
| 00613994204103 | K070742 | 000 |
| 00613994204110 | K070742 | 000 |
| 00613994204127 | K070742 | 000 |
| 00613994204134 | K070742 | 000 |
| 00613994208774 | K070742 | 000 |
| 00613994208828 | K070742 | 000 |
| 00613994212450 | K070742 | 000 |
| 00613994212467 | K070742 | 000 |
| 00613994204097 | K070742 | 000 |
| 00613994204080 | K070742 | 000 |
| 00613994204073 | K070742 | 000 |
| 00613994203939 | K070742 | 000 |
| 00613994203977 | K070742 | 000 |
| 00613994203984 | K070742 | 000 |
| 00613994203991 | K070742 | 000 |
| 00613994204004 | K070742 | 000 |
| 00613994204011 | K070742 | 000 |
| 00613994204059 | K070742 | 000 |
| 00613994204066 | K070742 | 000 |
| 00613994212474 | K070742 | 000 |