The following data is part of a premarket notification filed by Precision Surgery Ltd. with the FDA for Psl Anterior Cervical Plate System.
Device ID | K103819 |
510k Number | K103819 |
Device Name: | PSL ANTERIOR CERVICAL PLATE SYSTEM |
Classification | Appliance, Fixation, Spinal Intervertebral Body |
Applicant | PRECISION SURGERY LTD. 8202 SHERMAN ROAD Chesterland, OH 44026 -2141 |
Contact | Karen E Warden |
Correspondent | Karen E Warden PRECISION SURGERY LTD. 8202 SHERMAN ROAD Chesterland, OH 44026 -2141 |
Product Code | KWQ |
CFR Regulation Number | 888.3060 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-12-30 |
Decision Date | 2011-02-15 |
Summary: | summary |