KKY · Class II · 21 CFR 878.3500

FDA Product Code KKY: Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction

Leading manufacturers include Longeviti Neuro Solutions, LLC, Kimberly-Clark Corp. and Biomet, Inc..

25
Total
25
Cleared
164d
Avg days
1978
Since

FDA 510(k) Cleared Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction Devices (Product Code KKY)

25 devices
1–24 of 25
Cleared Jul 15, 2021
Longeviti PorousFit implant
K211514
Longeviti Neuro Solutions, LLC
General & Plastic Surgery · 59d
Cleared Nov 23, 1990
HTR POLYMER, HTR-MX
K904111
United States Surgical, A Division of Tyco Healthc
General & Plastic Surgery · 78d
Cleared Mar 08, 1990
UHMWPE SURGICAL MESH
K894478
Biomet, Inc.
General & Plastic Surgery · 233d
Cleared Aug 14, 1978
SURG. GOWN & DRAPE, LOW LINT TREATMENT
K781019
Kimberly-Clark Corp.
General & Plastic Surgery · 210d

About Product Code KKY - Regulatory Context