MAY · Class II · 21 CFR 888.3353

FDA Product Code MAY: Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous Cemented, Osteophilic Finish

Leading manufacturers include Biomet, Inc., Stryker Corp. and Howmedica Osteonics Corp..

4
Total
4
Cleared
113d
Avg days
2005
Since

FDA 510(k) Cleared Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous Cemented, Osteophilic Finish Devices (Product Code MAY)

4 devices
1–4 of 4
Cleared Aug 16, 2013
ABG III MONOLITHIC HIP STEM
K123604
Howmedica Osteonics Corp.
Orthopedic · 268d
Cleared May 25, 2011
ABG II MONOLITHIC HIP STEM
K110807
Stryker Corp.
Orthopedic · 63d
Cleared Feb 11, 2009
100KGY E-POLY ACETABULAR LINERS- ADDITIONAL PROFILES: +3 MAXROM AND +3 HI-WALL
K090103
Biomet, Inc.
Orthopedic · 27d

About Product Code MAY - Regulatory Context