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510(k) K992240

PILLAR MALAR IMPLANT by Pillar Surgical, Inc. — Product Code LZK

K992240 is an FDA 510(k) premarket notification submitted by Pillar Surgical, Inc. for the device "PILLAR MALAR IMPLANT". The FDA issued a decision of Substantially Equivalent on November 22, 1999. The device falls under product code LZK (Implant, Malar), a Class II device regulated under 21 CFR 878.3550. Pillar Surgical, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 1999
Date Received
July 2, 1999
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 Pillar Surgical, Inc.

  • K002633 — SILMAX PECTORAL IMPLANT (November 21, 2000)
  • K002629 — SILMAX CONTOUR CARVING BLOCK IMPLANT (November 20, 2000)
  • K992239 — PILLAR CHIN IMPLANT (November 22, 1999)
  • K992242 — PILLAR NASAL, DORSAL COLUMELLA AND NASAL DORSUM IMPLANTS (November 22, 1999)
  • K991970 — SCAREASE SHEETS & SCAREASE GEL (October 25, 1999)
  • K954382 — PROLASTIC SHEETING (November 29, 1995)

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)
  • 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)
  • K973574 — DURALASTIC ANATOMICAL MALAR IMPLANT (October 24, 1997)

FDA data resources