Spectrum Designs Anterior Chin Implant
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K980446 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 Anterior Chin Implant is a solid silicone elastomer prosthesis used for facial augmentation or reconstruction of chin deficiencies. It is a type of internal chin prosthesis. The device is made from medical grade solid silicone elastomer.
The implant is provided non-sterile and is available in six sizes. It is implanted by a surgeon into a pocket created in the mandibular region, either intraorally or extraorally. The device has been authorized with an FDA 510K clearance.
Frequently asked questions
What is the Spectrum Designs Anterior Chin Implant made of?
The implant is made from medical grade solid silicone elastomer, a durable and biocompatible material.
Is the Anterior Chin Implant supplied sterile?
No, the implant is provided non-sterile and must be sterilized before use.
How many sizes of the Anterior Chin Implant are available?
The implant is available in six sizes to accommodate different patient needs and anatomical requirements.
What is the regulatory status of the Spectrum Designs Anterior Chin Implant?
The device has been authorized with an FDA 510K clearance, indicating it is substantially equivalent to a 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: fda.innolitics.com, SPECTRUM DESIGNS ANTERIOR CHIN IMPLANT by SPECTRUM DESIGNS, INC. | FDA ..., PDF qdi2326 SUMMARY OF SAFETY AND EFFECTIVENESS SPECTRUM DESIGNS ANTERIOR ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K980446 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Spectrum Designs, Inc.
Sources (1)
- FDA 510(k) K980446 24 fields · synced Sep 21, 2026