The following data is part of a premarket notification filed by Link America, Inc. with the FDA for Link Shoulder Prosthesis Endo-model System.
| Device ID | K852365 |
| 510k Number | K852365 |
| Device Name: | LINK SHOULDER PROSTHESIS ENDO-MODEL SYSTEM |
| Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented |
| Applicant | LINK AMERICA, INC. C/O SURGICAL IMPLANTS, INC. 10 GREAT MEADOW LANE East Hanavor, NJ 07936 |
| Contact | Ed Schussler |
| Correspondent | Ed Schussler LINK AMERICA, INC. C/O SURGICAL IMPLANTS, INC. 10 GREAT MEADOW LANE East Hanavor, NJ 07936 |
| Product Code | KWS |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-06-04 |
| Decision Date | 1985-12-16 |