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510(k) K871071

OMEGA DORSAL COLUMELLA IMPLANTS by Omega Silicone, Inc. — Product Code FZE

K871071 is an FDA 510(k) premarket notification submitted by Omega Silicone, Inc. for the device "OMEGA DORSAL COLUMELLA IMPLANTS". The FDA issued a decision of Substantially Equivalent on April 13, 1987. The device falls under product code FZE (Prosthesis, Nose, Internal), a Class II device regulated under 21 CFR 878.3680. Omega Silicone, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 13, 1987
Date Received
March 18, 1987
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 Omega Silicone, Inc.

  • K871072 — OMEGA NASAL SEPTAL BUTTON (June 8, 1987)
  • K871070 — OMEGA SILICONE CHIN IMPLANT (May 11, 1987)
  • K871073 — OMEGA BIVALVE NASAL SPLINTS (May 11, 1987)
  • K871074 — OMEGA EXTENDED MALAR AND OMEGA CONTOURED MALAR (April 10, 1987)

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)
  • K992242 — PILLAR NASAL, DORSAL COLUMELLA AND NASAL DORSUM IMPLANTS (November 22, 1999)
  • K983755 — NASAL DORSAL SERIES (November 20, 1998)
  • K982753 — SEARE BIOMEDICAL NASAL IMPLANTS (September 30, 1998)

FDA data resources