The following data is part of a premarket notification filed by Richards Medical Co., Inc. with the FDA for Russell-taylor Intramedullary Knee Fusion Nails.
Device ID | K893377 |
510k Number | K893377 |
Device Name: | RUSSELL-TAYLOR INTRAMEDULLARY KNEE FUSION NAILS |
Classification | Rod, Fixation, Intramedullary And Accessories |
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 | HSB |
CFR Regulation Number | 888.3020 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-05-01 |
Decision Date | 1989-11-16 |