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

Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction

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

KKY is the FDA product code for Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction, a class II device type, regulated under 21 CFR 878.3500. As of , FDA records hold 25 510(k) clearances under this code, the most recent dated , and 9 recalls.

Classification record

Product code
KKY
Device name
Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
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
25
Ingested recalls
9

Clearances, product code KKY

By decision year
25 clearances under product code KKY with a decision year between 1978 and 2021, 2002 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code KKY by decision year
YearClearances
19781
19902
19921
19931
19942
19951
20023
20052
20071
20081
20101
20111
20131
20143
20151
20162
20211

Applicants with the most clearances

Product code KKY
Applicants holding the most 510(k) clearances under product code KKY
ApplicantClearances
Ceremed, Inc.4
Oxford Performance Materials, Inc.2
Associated Hospital Services, Inc.1
Biomet Ussc Orthopedics1
Zimmer GmbH1
Hohenstein Enterprises, Inc.1
Howmedica Osteonics Corp., dba Stryker Orthopaedics1
Kimberly-Clark Corporation1
Longeviti Neuro Solutions1
Matrix Surgical Holdings, LLC/Matrix Surgical USA1

Companies listing this code with FDA

Companies whose registered establishments list this code