510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
LGFClass I

Component, Cast

21 CFR 888.5940 / Orthopedic
FDA source (opens on fda.gov)

LGF is the FDA product code for Component, Cast, a class I device type, regulated under 21 CFR 888.5940. As of , FDA records hold 31 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
LGF
Device name
Component, Cast
Regulation
21 CFR 888.5940
Device class
Class I
Review panel
Orthopedic
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
Yes
Third party review eligible
No
Ingested clearances
31
Ingested recalls
0

Clearances, product code LGF

By decision year
31 clearances under product code LGF with a decision year between 1978 and 2005, 1987 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code LGF by decision year
YearClearances
19781
19812
19823
19832
19842
19852
19864
19875
19881
19902
19911
19931
19941
19961
19972
20051

Applicants with the most clearances

Product code LGF
Applicants holding the most 510(k) clearances under product code LGF
ApplicantClearances
Martin Medical6
Buckman Co., Inc.2
Carapace, Inc.2
Clinitex Medical Corp.2
Johnson & Johnson Professionals, Inc.2
Alba Health Care1
Beiersdorf, Inc.1
Conphar, Inc.1
Danek Medical, Inc.1
Depuy, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 51 companies shown, in name order