The following data is part of a premarket notification filed by Richards Medical Co., Inc. with the FDA for Stainless Steel Orthopaedic Cable System.
Device ID | K875156 |
510k Number | K875156 |
Device Name: | STAINLESS STEEL ORTHOPAEDIC CABLE SYSTEM |
Classification | Cerclage, Fixation |
Applicant | RICHARDS MEDICAL CO., INC. 1450 BROOKS RD. Memphis, TN 38116 |
Contact | Robert F Games |
Correspondent | Robert F Games RICHARDS MEDICAL CO., INC. 1450 BROOKS RD. Memphis, TN 38116 |
Product Code | JDQ |
CFR Regulation Number | 888.3010 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-12-15 |
Decision Date | 1988-01-20 |