The following data is part of a premarket notification filed by Link America, Inc. with the FDA for Link Contour Ribbed Hip Prostheses System.
| Device ID | K854465 |
| 510k Number | K854465 |
| Device Name: | LINK CONTOUR RIBBED HIP PROSTHESES SYSTEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | LINK AMERICA, INC. C/O SURGICAL IMPLANTS, INC. 10 GREAT MEADOW LANE East Hanavor, NJ 07936 |
| Contact | Edward B Schussler |
| Correspondent | Edward B Schussler LINK AMERICA, INC. C/O SURGICAL IMPLANTS, INC. 10 GREAT MEADOW LANE East Hanavor, NJ 07936 |
| Product Code | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-11-06 |
| Decision Date | 1986-02-10 |