The following data is part of a premarket notification filed by Medtronic Sofamor Danek, Inc. with the FDA for Lift Vb Spinal System.
Device ID | K010930 |
510k Number | K010930 |
Device Name: | LIFT VB SPINAL SYSTEM |
Classification | Spinal Vertebral Body Replacement Device |
Applicant | MEDTRONIC SOFAMOR DANEK, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
Contact | Richard Treharne |
Correspondent | Richard Treharne MEDTRONIC SOFAMOR DANEK, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
Product Code | MQP |
CFR Regulation Number | 888.3060 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-03-28 |
Decision Date | 2001-10-24 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00721902035388 | K010930 | 000 |
00721902035289 | K010930 | 000 |
00721902035234 | K010930 | 000 |
20721902068342 | K010930 | 000 |