The following data is part of a premarket notification filed by Centinel Spine, Inc. with the FDA for Midline (tm).
Device ID | K133286 |
510k Number | K133286 |
Device Name: | MIDLINE (TM) |
Classification | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
Applicant | CENTINEL SPINE, INC. 900 AIRPORT RD, STE #3B West Chester, PA 19380 |
Contact | John Parry |
Correspondent | John Parry CENTINEL SPINE, INC. 900 AIRPORT RD, STE #3B West Chester, PA 19380 |
Product Code | OVD |
CFR Regulation Number | 888.3080 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-10-25 |
Decision Date | 2014-01-09 |
Summary: | summary |