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510(k) K964443

SURGIFORM ANATOMICAL MALAR by Surgical Technology Laboratories, Inc. — Product Code LZK

K964443 is an FDA 510(k) premarket notification submitted by Surgical Technology Laboratories, Inc. for the device "SURGIFORM ANATOMICAL MALAR". The FDA issued a decision of Substantially Equivalent on December 20, 1996. The device falls under product code LZK (Implant, Malar), a Class II device regulated under 21 CFR 878.3550. Surgical Technology Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 1996
Date Received
November 6, 1996
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 Surgical Technology Laboratories, Inc.

  • K170582 — Saf-T-Vac Smoke and Fluid Evacuator (April 14, 2017)
  • K021889 — SURGIFORM AUGMENTATION MATERIAL (S.F.A.M.) (October 16, 2002)
  • K983755 — NASAL DORSAL SERIES (November 20, 1998)
  • K983756 — SURGIFORM ANATOMICAL MALAR (November 20, 1998)
  • K983754 — STANDARD CHIN (November 20, 1998)
  • K840835 — STRAITH DRAIN INSERTER (April 23, 1984)
  • K831078 — STRAITH ORAL AIRWAY (June 24, 1983)
  • K801074 — STRAITH NASAL IMPLANT (June 17, 1980)
  • K801072 — STRAITH NASAL SPLINT (June 17, 1980)
  • K801075 — STRAITH CHISEL FORCEPS (May 20, 1980)

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)
  • K980139 — SPECTRUM DESIGNS PROFILE MALAR IMPLANT (March 3, 1998)
  • K980141 — SPECTRUM DESIGNS PROJECTION MALAR IMPLANT (March 3, 1998)
  • K973502 — IMPLANTECH CONFORM BINDER SUBMALAR IMPLANT (November 7, 1997)

FDA data resources