The following data is part of a premarket notification filed by Turnkey Intergration Usa, Inc. with the FDA for Link Saddle Prothesis.
Device ID | K951355 |
510k Number | K951355 |
Device Name: | LINK SADDLE PROTHESIS |
Classification | Prosthesis, Hip, Hemi-, Femoral, Metal |
Applicant | TURNKEY INTERGRATION USA, INC. 6060 CASTLEWAY DR. WEST SUITE 236 Indianapolis, IN 46250 -1290 |
Contact | Douglas W Stuart |
Correspondent | Douglas W Stuart TURNKEY INTERGRATION USA, INC. 6060 CASTLEWAY DR. WEST SUITE 236 Indianapolis, IN 46250 -1290 |
Product Code | KWL |
CFR Regulation Number | 888.3360 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-03-08 |
Decision Date | 1995-05-25 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04026575047840 | K951355 | 000 |
04026575047765 | K951355 | 000 |