The following data is part of a premarket notification filed by Precision Spine, Inc. with the FDA for Interspinous Plate System.
| Device ID | K142378 |
| 510k Number | K142378 |
| Device Name: | Interspinous Plate System |
| Classification | Spinous Process Plate |
| Applicant | Precision Spine, Inc. 5 Sylvan Way Ste. 220 Parsippany, NJ 07930 |
| Contact | Michael C. Dawson |
| Correspondent | Kenneth C. Maxwell EMPIRICAL TESTING CORPORATION 4628 NORTHPARK DRIVE Colorado Springs, CO 80918 |
| Product Code | PEK |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-26 |
| Decision Date | 2014-12-18 |
| Summary: | summary |