The following data is part of a premarket notification filed by Smith & Nephew Richards, Inc. with the FDA for Simmons Plating System.
Device ID | K910681 |
510k Number | K910681 |
Device Name: | SIMMONS PLATING SYSTEM |
Classification | Appliance, Fixation, Spinal Intervertebral Body |
Applicant | SMITH & NEPHEW RICHARDS, INC. 1450 BROOKS RD. Memphis, TN 38116 |
Contact | Robert F Games |
Correspondent | Robert F Games SMITH & NEPHEW RICHARDS, INC. 1450 BROOKS RD. Memphis, TN 38116 |
Product Code | KWQ |
CFR Regulation Number | 888.3060 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-02-15 |
Decision Date | 1991-10-04 |