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, Biomet, Inc. and United States Surgical, A Division of Tyco Healthc.

25
Total
25
Cleared
164d
Avg days
1978
Since
Stable submission activity - 0 submissions in the last 2 years

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

About Product Code KKY - Regulatory Context

510(k) Submission Activity

25 total 510(k) submissions under product code KKY since 1978, with 25 receiving FDA clearance (average review time: 164 days).

Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.