The following data is part of a premarket notification filed by Waldemar Link Gmbh & Co. Kg with the FDA for Link Mp Reconstruction Prosthesis.
| Device ID | K142187 |
| 510k Number | K142187 |
| Device Name: | LINK MP RECONSTRUCTION PROSTHESIS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | WALDEMAR LINK GMBH & CO. KG BARKHAUSENWEG 10 Hamburg, DE 22339 |
| Contact | Thomas Mehler |
| Correspondent | Thomas Mehler WALDEMAR LINK GMBH & CO. KG BARKHAUSENWEG 10 Hamburg, DE 22339 |
| Product Code | LZO |
| Subsequent Product Code | JDI |
| Subsequent Product Code | LWJ |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-08 |
| Decision Date | 2014-11-06 |
| Summary: | summary |