The following data is part of a premarket notification filed by Richards Medical Co., Inc. with the FDA for Intramedullary Hip Screw.
Device ID | K895241 |
510k Number | K895241 |
Device Name: | INTRAMEDULLARY HIP SCREW |
Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
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 | KTT |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-08-21 |
Decision Date | 1990-01-04 |