Home / 510(k) Clearances / K172389

510(k) K172389

ePTFE-Coated Auricular Implant by Implantech Associates, Inc. — Product Code FZD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 2018
Date Received
August 8, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Ear, Internal
Device Class
Class II
Regulation Number
878.3590
Review Panel
SU
Submission Type

Other clearances by Implantech Associates, Inc.

  • K200610 — Customized Contour Implant (December 23, 2020)
  • K191130 — Customized Contour Implant (August 23, 2019)
  • K141027 — 3D EPTFE; ANATOMICAL CHIN, CURVILINEAR CHIN, EXTENDED ANATOMICAL CHIN IMPLANT, S (July 10, 2014)
  • K071470 — IMPLANTECH EPTFE SHEETING, MODEL EPTFE-XXX (August 31, 2007)
  • K052505 — CALF IMPLANT, MODEL EC17-X (November 4, 2005)
  • K052504 — GLUTEAL IMPLANT, MODELS RND 5-X, TRD 6-X (November 4, 2005)
  • K013732 — GELZONE (February 7, 2002)
  • K012419 — CONFORM SHEETING, MODEL IGEL (October 24, 2001)
  • K002886 — IMPLANTECH COMPOSITE FACIAL IMPLANTS (MALAR, CHIN, AND NASAL) (November 24, 2000)
  • K973502 — IMPLANTECH CONFORM BINDER SUBMALAR IMPLANT (November 7, 1997)

Other clearances for product code FZD

  • K863939 — POREX(TM) EAR PROSTHESIS (October 24, 1986)
  • K844960 — CANAL WALL PROSTHESIS (February 26, 1985)