The Permaridge Matrix Chin

FDA 510(k) K931500 · Applied Biomaterial Technologies

Substantially Equivalent

510(k) numberK931500

Submission

Device name
The Permaridge Matrix Chin
Applicant
Applied Biomaterial Technologies
Silverdale, WA, US
Received
March 25, 1993
Decision date
November 17, 1994
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
FWP – Prosthesis, Chin, Internal
Device class
Class II (moderate risk)
Regulation
21 CFR 878.3550
Specialty
General, Plastic Surgery
Implant
Yes

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More from Howmedica Osteonics Corp.

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K945552Duralastic SheetingMIB · Traditional 01/31/1995SE
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K902285The Magnum Chin ImplantFWP · Traditional 09/12/1990SE
K902284Zymalar ImplantLZK · Traditional 09/12/1990SE
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Questions and answers

When was The Permaridge Matrix Chin cleared by the FDA?

The Permaridge Matrix Chin (K931500) received a 510(k) decision of Substantially Equivalent on November 17, 1994, 602 days after the submission was received.

What is the product code of K931500?

The FDA product code is FWP – Prosthesis, Chin, Internal, a Class II (moderate risk) device regulated under 21 CFR 878.3550.