LGE · Class II · 21 CFR 888.3530

FDA Product Code LGE: Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Trunnion-bearing

Leading manufacturers include Howmedica Corp. and Howmedica Osteonics Corp..

2
Total
2
Cleared
26d
Avg days
1981
Since

FDA 510(k) Cleared Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Trunnion-bearing Devices (Product Code LGE)

2 devices
1–2 of 2
Cleared Aug 12, 1999
KINEMATIC II ROTATING HINGE KNEE
K992346
Howmedica Osteonics Corp.
Orthopedic · 30d
Cleared Jul 01, 1981
KINEMATIC ROTATING HINGE TOTAL KNEE PR.
K811630
Howmedica Corp.
Orthopedic · 22d

About Product Code LGE - Regulatory Context