Panels › Orthopedic › Product code MAY · Class 2
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish
Regulation 888.3353
0510(k)s in 12 months (4 all time)
0recalls in 12 months (19 all time)
5recalls that name a 510(k)
Top companies in MAY
| Company | 510(k)s | Recalls |
|---|---|---|
| Stryker Howmedica Osteonics Corp. | 0 | 19 |
| Biomet, Inc. | 1 | 0 |
| Howmedica Osteonics Corp. | 1 | 0 |
| Portland Orthopaedics Pty. , Ltd. | 1 | 0 |
| Stryker Corp. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 16, 2013 | K123604 | ABG III MONOLITHIC HIP STEM Howmedica Osteonics Corp. | MAY |
| May 25, 2011 | K110807 | ABG II MONOLITHIC HIP STEM Stryker Corp. | MAY |
| Feb 11, 2009 | K090103 | 100KGY E-POLY ACETABULAR LINERS- ADDITIONAL PROFILES: +3 MAXROM AND +3 HI-WALL Biomet, Inc. | MAY |
| Oct 7, 2005 | K051844 | EQUATOR PLUS ACETABULAR CUP SYSTEM Portland Orthopaedics Pty. , Ltd. | MAY |
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