K142187 is an FDA 510(k) clearance for the LINK MP RECONSTRUCTION PROSTHESIS. This device is classified as a Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (Class II - Special Controls, product code LZO).
Submitted by Waldemar Link GmbH & Co. KG (Hamburg, DE). The FDA issued a Cleared decision on November 6, 2014, 90 days after receiving the submission on August 8, 2014.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3353.
| 510(k) Number | K142187 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 08, 2014 |
| Decision Date | November 06, 2014 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | LZO — Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3353 |