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 | K151863 |
510k Number | K151863 |
Device Name: | Precision Spine Interspinous Plate System |
Classification | Spinous Process Plate |
Applicant | PRECISION SPINE, INC. 5 SYLVAN WAY, SUITE 220 Parsippany, NJ 07930 |
Contact | Michael C. Dawson |
Correspondent | Kenneth C. Maxwell EMPIRICAL TESTING CORP. 4628 NORTHPARK DRIVE Colorado Springs, CO 80918 |
Product Code | PEK |
CFR Regulation Number | 888.3050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-07-08 |
Decision Date | 2015-08-07 |
Summary: | summary |