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510(k) K871070

OMEGA SILICONE CHIN IMPLANT by Omega Silicone, Inc. — Product Code FWP

K871070 is an FDA 510(k) premarket notification submitted by Omega Silicone, Inc. for the device "OMEGA SILICONE CHIN IMPLANT". The FDA issued a decision of Substantially Equivalent on May 11, 1987. The device falls under product code FWP (Prosthesis, Chin, Internal), a Class II device regulated under 21 CFR 878.3550. Omega Silicone, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 11, 1987
Date Received
March 18, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Chin, Internal
Device Class
Class II
Regulation Number
878.3550
Review Panel
SU
Submission Type

Other clearances by Omega Silicone, Inc.

  • K871072 — OMEGA NASAL SEPTAL BUTTON (June 8, 1987)
  • K871073 — OMEGA BIVALVE NASAL SPLINTS (May 11, 1987)
  • K871071 — OMEGA DORSAL COLUMELLA IMPLANTS (April 13, 1987)
  • K871074 — OMEGA EXTENDED MALAR AND OMEGA CONTOURED MALAR (April 10, 1987)

Other clearances for product code FWP

  • K254233 — MEDPOR Customized Implant Kit (March 12, 2026)
  • K232593 — FITme Customized Silicone Implant (November 22, 2023)
  • K200610 — Customized Contour Implant (December 23, 2020)
  • K191130 — Customized Contour Implant (August 23, 2019)
  • K191916 — Stryker CMF MEDPOR Priority Customized Implant Kit (August 15, 2019)
  • K153508 — Stryker CMF MEDPOR Customized Implant (February 5, 2016)
  • K152463 — SU-POR Patient-Specific Cranial Implant, SU-POR Patient-Specific Facial Implant (January 20, 2016)
  • K143173 — Stryker CMF MEDPOR Customized Implant (March 23, 2015)
  • K141027 — 3D EPTFE; ANATOMICAL CHIN, CURVILINEAR CHIN, EXTENDED ANATOMICAL CHIN IMPLANT, S (July 10, 2014)
  • K121315 — STRYKER CMF MEDPOR CUSTOMIZED IMPLANT (November 1, 2012)

FDA data resources