K090103 is an FDA 510(k) clearance for the 100KGY E-POLY ACETABULAR LINERS- ADDITIONAL PROFILES: +3 MAXROM AND +3 HI-WALL. This device is classified as a Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous Cemented, Osteophilic Finish (Class II - Special Controls, product code MAY).
Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on February 11, 2009, 27 days after receiving the submission on January 15, 2009.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3353.
| 510(k) Number | K090103 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 15, 2009 |
| Decision Date | February 11, 2009 |
| Days to Decision | 27 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | MAY — Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous Cemented, Osteophilic Finish |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3353 |