Home / 510(k) Clearances / K973502

510(k) K973502

IMPLANTECH CONFORM BINDER SUBMALAR IMPLANT by Implantech Associates, Inc. — Product Code LZK

K973502 is an FDA 510(k) premarket notification submitted by Implantech Associates, Inc. for the device "IMPLANTECH CONFORM BINDER SUBMALAR IMPLANT". The FDA issued a decision of Substantially Equivalent on November 7, 1997. The device falls under product code LZK (Implant, Malar), a Class II device regulated under 21 CFR 878.3550. Implantech Associates, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 7, 1997
Date Received
September 16, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Implant, Malar
Device Class
Class II
Regulation Number
878.3550
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)
  • K172389 — ePTFE-Coated Auricular Implant (July 18, 2018)
  • 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)
  • K052504 — GLUTEAL IMPLANT, MODELS RND 5-X, TRD 6-X (November 4, 2005)
  • K052505 — CALF IMPLANT, MODEL EC17-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)

Other clearances for product code LZK

  • K021419 — AART MALAR IMPLANT (July 2, 2002)
  • K002886 — IMPLANTECH COMPOSITE FACIAL IMPLANTS (MALAR, CHIN, AND NASAL) (November 24, 2000)
  • K992240 — PILLAR MALAR IMPLANT (November 22, 1999)
  • K983756 — SURGIFORM ANATOMICAL MALAR (November 20, 1998)
  • K982763 — SEARE BIOMEDICAL MALAR IMPLANTS (September 30, 1998)
  • K981835 — SILIMED MALAR IMPLANT (July 9, 1998)
  • K980140 — SPECTRUM DESIGNS MEDIAL MALAR IMPLANT (March 3, 1998)
  • K980141 — SPECTRUM DESIGNS PROJECTION MALAR IMPLANT (March 3, 1998)
  • K980139 — SPECTRUM DESIGNS PROFILE MALAR IMPLANT (March 3, 1998)
  • K973574 — DURALASTIC ANATOMICAL MALAR IMPLANT (October 24, 1997)

FDA data resources