Omega Dorsal Columella Implants

FDA 510(k) K871071 · Omega Silicone, Inc.

Substantially Equivalent

510(k) numberK871071

Submission

Device name
Omega Dorsal Columella Implants
Applicant
Omega Silicone, Inc.
Santa Barbara, CA, US
Received
March 18, 1987
Decision date
April 13, 1987
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
FZE – Prosthesis, Nose, Internal
Device class
Class II (moderate risk)
Regulation
21 CFR 878.3680
Specialty
General, Plastic Surgery
Implant
Yes

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K241253Medicon Epiplating SystemFZE · Traditional Cmf Medicon Surgical, Inc.12/12/2024SE
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K090803Hanson Medical Facial ImplantsFZE · Traditional Hanson Medical, Inc.06/30/2010SE
K090630Nobel Biocare Endosseous Implants (Maxillofacial Indication)FZE · Traditional Nobel Biocare AB06/02/2009SE
K071018Monarch Nasal ImplantFZE · Traditional Hanson Medical, Inc.05/25/2007SE
K041690Monarch Nasal ImplantFZE · Traditional Hanson Medical, Inc.02/11/2005SE
K021418Aart Nasal ImplantFZE · Traditional Aesthetic and Reconstructive Technologies, Inc.07/02/2002SE
K992242Pillar Nasal, Dorsal Columella and Nasal Dorsum ImplantsFZE · Traditional Pillar Surgical, Inc.11/22/1999SE
K983755Nasal Dorsal SeriesFZE · Special Surgical Technology Laboratories, Inc.11/20/1998SE
K982753Seare Biomedical Nasal ImplantsFZE · Traditional Seare Biomedical Corp.09/30/1998SE

More from Seare Biomedical Corp.

510(k)DeviceDecision
K871072Omega Nasal Septal ButtonLFB · Traditional 06/08/1987SE
K871073Omega Bivalve Nasal SplintsFYI · Traditional 05/11/1987SE
K871070Omega Silicone Chin ImplantFWP · Traditional 05/11/1987SE
K871074Omega Extended Malar and Omega Contoured MalarFWP · Traditional 04/10/1987SE

Questions and answers

When was Omega Dorsal Columella Implants cleared by the FDA?

Omega Dorsal Columella Implants (K871071) received a 510(k) decision of Substantially Equivalent on April 13, 1987, 26 days after the submission was received.

What is the product code of K871071?

The FDA product code is FZE – Prosthesis, Nose, Internal, a Class II (moderate risk) device regulated under 21 CFR 878.3680.