The following data is part of a premarket notification filed by Medtronic Sofamor Danek Usa, Inc with the FDA for Pivox(tm) Oblique Lateral Spinal System.
Device ID | K152277 |
510k Number | K152277 |
Device Name: | PIVOX(tm) Oblique Lateral Spinal System |
Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
Applicant | MEDTRONIC SOFAMOR DANEK USA, INC 1800 PYRAMID PLACE Memphis, TN 38132 |
Contact | Lila Joe |
Correspondent | Lila Joe MEDTRONIC SOFAMOR DANEK USA, INC 1800 PYRAMID PLACE Memphis, TN 38132 |
Product Code | MAX |
Subsequent Product Code | KWQ |
Subsequent Product Code | OVD |
CFR Regulation Number | 888.3080 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-08-12 |
Decision Date | 2015-11-13 |
Summary: | summary |