The following data is part of a premarket notification filed by Waldemar Link Gmbh & Co.kg with the FDA for Mp Reconstruction System.
| Device ID | K213675 |
| 510k Number | K213675 |
| Device Name: | MP Reconstruction System |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | Waldemar Link GmbH & Co.KG Oststrabe 4-10 Norderstedt, DE 22844 |
| Contact | Lydia Ditter |
| Correspondent | Lydia Ditter Waldemar Link GmbH & Co. KG Ostsraße 4-10 Norderstedt, DE 22844 |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-11-22 |
| Decision Date | 2022-04-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04026575342303 | K213675 | 000 |
| 04026575342259 | K213675 | 000 |
| 04026575342280 | K213675 | 000 |
| 04026575342310 | K213675 | 000 |
| 04026575342204 | K213675 | 000 |
| 04026575342211 | K213675 | 000 |
| 04026575342235 | K213675 | 000 |
| 04026575342242 | K213675 | 000 |
| 04026575342266 | K213675 | 000 |
| 04026575342273 | K213675 | 000 |
| 04026575342297 | K213675 | 000 |
| 04026575342228 | K213675 | 000 |