Cleared Traditional

K904657 - FLOWERS DORSAL COLUMELLA IMPLANT

K904657 is the FDA 510(k) clearance for FLOWERS DORSAL COLUMELLA IMPLANT by Implantech Associates, Inc.. It is a Class 2 General & Plastic Surgery device (product code FZE) cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K904657 · Implantech Associates, Inc. · General & Plastic Surgery device
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Dec 1990
Decision
64d
Days
Class 2
Risk

K904657 is an FDA 510(k) clearance for the FLOWERS DORSAL COLUMELLA IMPLANT. Classified as Prosthesis, Nose, Internal (product code FZE), Class II - Special Controls.

Submitted by Implantech Associates, Inc. (Washington, US). The FDA issued a Cleared decision on December 18, 1990 after a review of 64 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.3680 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Implantech Associates, Inc. devices

Submission Details

510(k) Number K904657 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1990
Decision Date December 18, 1990
Days to Decision 64 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 115d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FZE Prosthesis, Nose, Internal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3680
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 - FZE Prosthesis, Nose, Internal

Devices cleared under the same product code (FZE) and FDA review panel - the closest regulatory comparables to K904657.
NOBEL BIOCARE ENDOSSEOUS IMPLANTS (MAXILLOFACIAL INDICATION)
K090630 · Nobel Biocare AB · Jun 2009
BA-CPAS
K945154 · Nobelpharma USA, Inc. · Jan 1995
NASAL DORSUM
K925743 · Smith & Nephew Richards, Inc. · Aug 1993
SILASTIC NASAL IMPLANT S-TYPE
K880405 · Dow Corning Wright · Feb 1988
PLASTI-PORE SEPTAL BUTTON
K781574 · Richard'S Medical Equip., Inc. · Sep 1978