The following data is part of a premarket notification filed by Medtronic Sofamor Danek Usa, Inc. with the FDA for Capstone Spinal System.
Device ID | K121760 |
510k Number | K121760 |
Device Name: | CAPSTONE SPINAL SYSTEM |
Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
Applicant | MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
Contact | Brad Sheals |
Correspondent | Brad Sheals MEDTRONIC SOFAMOR DANEK USA, INC. 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 | 2012-06-15 |
Decision Date | 2012-08-29 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00885074417615 | K121760 | 000 |