The following data is part of a premarket notification filed by Waldemar Link Gmbh & Co. Kg with the FDA for Interplanta Sp Total Hip Prosthesis.
| Device ID | K790488 |
| 510k Number | K790488 |
| Device Name: | INTERPLANTA SP TOTAL HIP PROSTHESIS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | WALDEMAR LINK GMBH & CO. KG 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-03-12 |
| Decision Date | 1979-03-28 |