MAY — Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish Class II
FDA product code MAY covers "Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish", a Class II medical device regulated under 21 CFR 888.3353. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants. At least 4 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- MAY
- Device Class
- Class II
- Regulation Number
- 888.3353
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K123604 | howmedica osteonics | ABG III MONOLITHIC HIP STEM | August 16, 2013 |
| K110807 | stryker | ABG II MONOLITHIC HIP STEM | May 25, 2011 |
| K090103 | biomet | 100KGY E-POLY ACETABULAR LINERS- ADDITIONAL PROFILES: +3 MAXROM AND +3 HI-WALL | February 11, 2009 |
| K051844 | portland orthopaedics pty. | EQUATOR PLUS ACETABULAR CUP SYSTEM | October 7, 2005 |