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Spectrum Designs Anatomical Chin Implant

FDA 510(k)

Class II (US FDA 510(k))

510(k) K980462

by Spectrum Designs, Inc.

Identifiers

510(k) Number
K980462 FDA 510(k)
FDA Product Code
FWP FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.3550 FDA 510(k)
Regulation Number
878.3550 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Spectrum Designs Anatomical Chin Implant is a prosthesis for the chin, internal, classified under device class 2. It is intended to augment or reconstruct congenital or traumatic chin deficiencies.

The device is supplied sterile and is for single-use only. It is available in various sizes, including the S250-9x4S Series, and is regulated under FDA 510(k) clearance K980462 with a substantially equivalent decision. Storage and handling should follow manufacturer guidelines for sterile, single-use implants.

Frequently asked questions

What is the Spectrum Designs Anatomical Chin Implant used for?

It is intended to augment or reconstruct congenital or traumatic chin deficiencies as an internal prosthesis for the chin, providing structural support and contour improvement in reconstructive or aesthetic procedures.

How is the Spectrum Designs Anatomical Chin Implant supplied and is it reusable?

The device is supplied sterile and is designated for single-use only; it must not be resterilized or reused due to risks of contamination, material degradation, and compromised patient safety.

What sizes or models are available for the Spectrum Designs Anatomical Chin Implant?

It is available in various sizes, including the S250-9x4S Series, which refers to a specific dimensional variant within the product line designed to accommodate different patient anatomies.

What storage conditions are required for the Spectrum Designs Anatomical Chin Implant?

Storage and handling should follow the manufacturer’s guidelines for sterile, single-use implants, typically involving a clean, dry, temperature-controlled environment to maintain sterility and device integrity until use.

What regulatory pathway was used for the Spectrum Designs Anatomical Chin Implant?

The device received FDA 510(k) clearance under K980462 with a substantially equivalent decision, meaning it was found to be as safe and effective as a legally marketed predicate device.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: SPECTRUM DESIGNS ANATOMICAL CHIN IMPLANT (K980462) — FDA 510 (k ..., Spectrum Designs Anatomical Chin Implant 510 (k) FDA Premarket ..., Spectrum Designs, Inc. FDA 510 (k) Products (1994-1999), Spectrum Designs Anatomical Chin Implant - Beudamed, Chin implant - S250-9x4S Series - Spectrum Designs Medical - anatomical ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Spectrum Designs, Inc.

Sources (1)

  • FDA 510(k) K980462 24 fields · synced Sep 24, 2026