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 |