The following data is part of a premarket notification filed by Link America, Inc. with the FDA for Link Metal-backed Acetabular Cups.
| Device ID | K854935 |
| 510k Number | K854935 |
| Device Name: | LINK METAL-BACKED ACETABULAR CUPS |
| Classification | Prosthesis, Hip, Semi-constrained (metal Cemented Acetabular Component) |
| 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 | JDL |
| CFR Regulation Number | 888.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-10 |
| Decision Date | 1986-03-05 |