The following data is part of a premarket notification filed by Waldemar Link Gmbh & Co. Kg with the FDA for Link Mp Monoblock Hip Prosthesis.
| Device ID | K183141 |
| 510k Number | K183141 |
| Device Name: | LINK MP Monoblock Hip Prosthesis |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | Waldemar Link GmbH & Co. KG Oststraße 4-10 Norderstedt, DE 22844 |
| Contact | Andre Von Malotki |
| Correspondent | Andre Von Malotki Waldemar Link GmbH & Co. KG Oststraße 4-10 Norderstedt, DE 22844 |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-13 |
| Decision Date | 2019-02-08 |
| Summary: | summary |