The following data is part of a premarket notification filed by Smith & Nephew Richards, Inc. with the FDA for Anterior Cervial Plating System.
Device ID | K943523 |
510k Number | K943523 |
Device Name: | ANTERIOR CERVIAL PLATING SYSTEM |
Classification | Appliance, Fixation, Spinal Intervertebral Body |
Applicant | SMITH & NEPHEW RICHARDS, INC. 1450 E. BROOKS RD. Memphis, TN 38116 |
Contact | Jeff Cobb |
Correspondent | Jeff Cobb SMITH & NEPHEW RICHARDS, INC. 1450 E. BROOKS RD. Memphis, TN 38116 |
Product Code | KWQ |
CFR Regulation Number | 888.3060 [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-07-21 |
Decision Date | 1994-12-19 |