The following data is part of a premarket notification filed by Precision Spine, Inc. with the FDA for Precision Spine Interspinous Plate System.
| Device ID | K160568 |
| 510k Number | K160568 |
| Device Name: | Precision Spine Interspinous Plate System |
| Classification | Spinous Process Plate |
| Applicant | Precision Spine, Inc. 2050 Executive Drive Pearl, MS 39280 |
| Contact | Michael C. Dawson |
| Correspondent | Michael C. Dawson Precision Spine, Inc. 2050 Executive Drive Pearl, MS 39208 |
| Product Code | PEK |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-29 |
| Decision Date | 2016-05-04 |
| Summary: | summary |