Cleared Traditional

K980462 - SPECTRUM DESIGNS ANATOMICAL CHIN IMPLANT

K980462 is an FDA 510(k) clearance for SPECTRUM DESIGNS ANATOMICAL CHIN IMPLANT, manufactured by Spectrum Designs, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FWP cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K980462 · Spectrum Designs, Inc. · General & Plastic Surgery device
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May 1998
Decision
90d
Days
Class 2
Risk

K980462 is an FDA 510(k) clearance for the SPECTRUM DESIGNS ANATOMICAL CHIN IMPLANT. Classified as Prosthesis, Chin, Internal (product code FWP), Class II - Special Controls.

Submitted by Spectrum Designs, Inc. (Goleta, US). The FDA issued a Cleared decision on May 6, 1998 after a review of 90 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.3550 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Spectrum Designs, Inc. devices

FDA 510(k) Submission Details - K980462

510(k) Number K980462 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 1998
Decision Date May 06, 1998
Days to Decision 90 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 115d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FWP Device Classification - Class 2, Special Controls

Product Code FWP Prosthesis, Chin, Internal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3550
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - FWP Prosthesis, Chin, Internal

All 38
Devices cleared under the same product code (FWP) and FDA review panel - the closest regulatory comparables to K980462.
SPECTRUM DESIGNS BILATERAL GROOVE CHIN IMPLANT
K980444 · Spectrum Designs, Inc. · May 1998
SPECTRUM DESIGNS CONCAVE BACK CHIN IMPLANT
K980445 · Spectrum Designs, Inc. · May 1998
SPECTRUM DESIGNS ANTERIOR CHIN IMPLANT
K980446 · Spectrum Designs, Inc. · May 1998
SPECTRUM DESIGNS CURVILINEAR CHIN IMPLANT
K980463 · Spectrum Designs, Inc. · May 1998
SPECTRUM DESIGNS SYMMETRICAL CHIN IMPLANT
K980138 · Spectrum Designs, Inc. · Apr 1998
SPECTRUM DESIGNS CLEFT CHIN IMPLANT
K980461 · Spectrum Designs, Inc. · Mar 1998