Product code LGE— Orthopedic
KINEMATIC II ROTATING HINGE KNEE
- Classification name
- Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Trunnion-Bearing
- Device class
- Class 2
- Regulation
- 21 CFR 888.3530
- Advisory panel
- Orthopedic
- Total cleared
- 2
- First cleared
- Most recent
Market context for product code LGE
FDA has cleared devices under product code LGE between 1981 and 1999, filed by 2 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
- 1999
- 1981
Top applicants under product code LGE
Recent clearances under product code LGE
Data sourced from openFDA. This site is unofficial and independent of the FDA.