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510(k) K992242

PILLAR NASAL, DORSAL COLUMELLA AND NASAL DORSUM IMPLANTS by Pillar Surgical, Inc. — Product Code FZE

K992242 is an FDA 510(k) premarket notification submitted by Pillar Surgical, Inc. for the device "PILLAR NASAL, DORSAL COLUMELLA AND NASAL DORSUM IMPLANTS". The FDA issued a decision of Substantially Equivalent on November 22, 1999. The device falls under product code FZE (Prosthesis, Nose, Internal), a Class II device regulated under 21 CFR 878.3680. 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
Prosthesis, Nose, Internal
Device Class
Class II
Regulation Number
878.3680
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)
  • K992240 — PILLAR MALAR IMPLANT (November 22, 1999)
  • K991970 — SCAREASE SHEETS & SCAREASE GEL (October 25, 1999)
  • K954382 — PROLASTIC SHEETING (November 29, 1995)

Other clearances for product code FZE

  • K241253 — Medicon Epiplating System (December 12, 2024)
  • K161548 — Osseointegrated Fixtures (December 1, 2016)
  • K090803 — HANSON MEDICAL FACIAL IMPLANTS (June 30, 2010)
  • K090630 — NOBEL BIOCARE ENDOSSEOUS IMPLANTS (MAXILLOFACIAL INDICATION) (June 2, 2009)
  • K071018 — MONARCH NASAL IMPLANT (May 25, 2007)
  • K041690 — MONARCH NASAL IMPLANT (February 11, 2005)
  • K021418 — AART NASAL IMPLANT (July 2, 2002)
  • K983755 — NASAL DORSAL SERIES (November 20, 1998)
  • K982753 — SEARE BIOMEDICAL NASAL IMPLANTS (September 30, 1998)
  • K981833 — SILIMED NASAL L SHAPED IMPLANT (June 26, 1998)

FDA data resources