The following data is part of a premarket notification filed by Waldemar Link Gmbh & Co. Kg with the FDA for Link Cementless Screw-in Acetabular Cup.
| Device ID | K843950 |
| 510k Number | K843950 |
| Device Name: | LINK CEMENTLESS SCREW-IN ACETABULAR CUP |
| Classification | Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component) |
| 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 | KWA |
| CFR Regulation Number | 888.3330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-10-09 |
| Decision Date | 1985-06-03 |