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

Prosthesis, Hip, Semi-Constrained, Composite/Metal

21 CFR 888.3340 / Orthopedic
FDA source (opens on fda.gov)

KMC is the FDA product code for Prosthesis, Hip, Semi-Constrained, Composite/Metal, a class II device type, regulated under 21 CFR 888.3340. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
KMC
Device name
Prosthesis, Hip, Semi-Constrained, Composite/Metal
Regulation
21 CFR 888.3340
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
3
Ingested recalls
1

Clearances, product code KMC

By decision year
3 clearances under product code KMC with a decision year between 1985 and 1994, 1985 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code KMC by decision year
YearClearances
19852
19941

Applicants with the most clearances

Product code KMC
Applicants holding the most 510(k) clearances under product code KMC
ApplicantClearances
Zimmer GmbH2
Intermedics Orthopedics1

Companies listing this code with FDA

Companies whose registered establishments list this code