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

Prosthesis, Ptfe/Carbon-Fiber

21 CFR 878.3500 / General, Plastic Surgery
FDA source (opens on fda.gov)

KDA is the FDA product code for Prosthesis, Ptfe/Carbon-Fiber, a class II device type, regulated under 21 CFR 878.3500. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
KDA
Device name
Prosthesis, Ptfe/Carbon-Fiber
Regulation
21 CFR 878.3500
Device class
Class II
Review panel
General, Plastic Surgery
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code KDA

By decision year
1 clearance under product code KDA with a decision year between 1986 and 1986, 1986 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code KDA by decision year
YearClearances
19861

Applicants with the most clearances

Product code KDA
Applicants holding the most 510(k) clearances under product code KDA
ApplicantClearances
Medcomp Technologies, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code KDA.