The following data is part of a premarket notification filed by Waldemar Link Gmbh & Co. Kg with the FDA for Lidgren-lund Femoral Dysplasia Hip Prosthesis Sys.
| Device ID | K852705 |
| 510k Number | K852705 |
| Device Name: | LIDGREN-LUND FEMORAL DYSPLASIA HIP PROSTHESIS SYS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | WALDEMAR LINK GMBH & CO. KG 10 GREAT MEADOW LN. E. Hanover, NJ 07936 |
| Contact | Ed Schussler |
| Correspondent | Ed Schussler WALDEMAR LINK GMBH & CO. KG 10 GREAT MEADOW LN. E. Hanover, 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 | 1985-06-26 |
| Decision Date | 1985-08-13 |