510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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LGEClass II

Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Trunnion-Bearing

21 CFR 888.3530 / Orthopedic
FDA source (opens on fda.gov)

LGE is the FDA product code for Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Trunnion-Bearing, a class II device type, regulated under 21 CFR 888.3530. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
LGE
Device name
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Trunnion-Bearing
Regulation
21 CFR 888.3530
Device class
Class II
Review panel
Orthopedic
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
1

Clearances, product code LGE

By decision year
2 clearances under product code LGE with a decision year between 1981 and 1999, 1981 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code LGE by decision year
YearClearances
19811
19991

Applicants with the most clearances

Product code LGE
Applicants holding the most 510(k) clearances under product code LGE
ApplicantClearances
Howmedica Corp.1
Howmedica Osteonics Corp1

Companies listing this code with FDA

Companies whose registered establishments list this code