The following data is part of a premarket notification filed by Link America, Inc. with the FDA for Link Mp Reconstruction Hip.
| Device ID | K955296 |
| 510k Number | K955296 |
| Device Name: | LINK MP RECONSTRUCTION HIP |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | LINK AMERICA, INC. 6060 CASTLEWAY DR. SUITE 236 Indianapolis, IN 46250 |
| Contact | Douglas W Stuart |
| Correspondent | Douglas W Stuart LINK AMERICA, INC. 6060 CASTLEWAY DR. SUITE 236 Indianapolis, IN 46250 |
| Product Code | JDI |
| Subsequent Product Code | LWJ |
| Subsequent Product Code | LZO |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-16 |
| Decision Date | 1996-02-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04026575323203 | K955296 | 000 |
| 04026575206001 | K955296 | 000 |
| 04026575203055 | K955296 | 000 |