Submission Details
| 510(k) Number | K160124 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 20, 2016 |
| Decision Date | April 04, 2016 |
| Days to Decision | 75 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
Cleared
Special
LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation System
Apr 2016
Decision
75d
Days
Class 2
Risk
About This 510(k) Submission
K160124 is an FDA 510(k) clearance for the LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation System, a Orthosis, Spinal Pedicle Fixation (Class II — Special Controls, product code MNI), submitted by Spinevision S.A. (Antony, FR). The FDA issued a Cleared decision on April 4, 2016, 75 days after receiving the submission on January 20, 2016. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.
Device Classification
| Product Code | MNI — Orthosis, Spinal Pedicle Fixation |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 888.3070 |
Manufacturer
Similar Devices — MNI Orthosis, Spinal Pedicle Fixation
All 302
K171497 · Mikron Makina Sanayi Ticaret Co. , Ltd.
· Oct 2017
K160731 · CG Bio Co., Ltd.
· Oct 2016
K151458 · Double Medical Technology, Inc.
· Aug 2016
K153273 · Medacta International S.A.
· Jun 2016
K160320 · Shandong Weigao Orthopaedic Device Co., Ltd.
· Apr 2016
K160003 · Spine Wave, Inc.
· Feb 2016
More from Spinevision S.A.
View all
K153783
· MAX · May 2016
K133575
· MNH · Jun 2014
K130302
· MNI · Jul 2013
K112607
· NKB · Jun 2012