Product code MAY— Orthopedic
100KGY E-POLY ACETABULAR LINERS- ADDITIONAL PROFILES: +3 MAXROM AND +3 HI-WALL
- Classification name
- Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish
- Device class
- Class 2
- Regulation
- 21 CFR 888.3353
- Advisory panel
- Orthopedic
- Total cleared
- 4
- First cleared
- Most recent
Market context for product code MAY
FDA has cleared devices under product code MAY between 2005 and 2013, filed by 4 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2013
- 2011
- 2009
- 2005
Top applicants under product code MAY
Recent clearances under product code MAY
Data sourced from openFDA. This site is unofficial and independent of the FDA.