Cleared Traditional

K900927 - CODERE-DURETTE ORBITAL FLOOR IMPLANT

K900927 is an FDA 510(k) clearance for CODERE-DURETTE ORBITAL FLOOR IMPLANT, manufactured by Oculo Plastik, Inc.. The device is a Class 2 Ophthalmic device with product code HQX cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K900927 · Oculo Plastik, Inc. · Ophthalmic device
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Optimized for regulatory review, auditing and printing
May 1990
Decision
77d
Days
Class 2
Risk

K900927 is an FDA 510(k) clearance for the CODERE-DURETTE ORBITAL FLOOR IMPLANT. Classified as Implant, Orbital, Extra-ocular (product code HQX), Class II - Special Controls.

Submitted by Oculo Plastik, Inc. (Montreal, Quebec Canada, CA). The FDA issued a Cleared decision on May 15, 1990 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.3340 - the FDA ophthalmic 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.

FDA 510(k) Submission Details - K900927

510(k) Number K900927 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 1990
Decision Date May 15, 1990
Days to Decision 77 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 110d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HQX Device Classification - Class 2, Special Controls

Product Code HQX Implant, Orbital, Extra-ocular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.3340
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 Ophthalmic devices follow this clearance model.

Regulatory Peers - HQX Implant, Orbital, Extra-ocular

All 15
Devices cleared under the same product code (HQX) and FDA review panel - the closest regulatory comparables to K900927.
TAMCENAN OCULAR EXPLANTS AND BANDS
K902308 · Tamcenan Corp. · Jun 1990
O'DONNELL, SOCKET RECONSTRUCTION PROSTHESES
K901002 · Oculo Plastik, Inc. · May 1990
PUTTERMAN-SCOTT, SOCKET RECONSTRUCTION BILATERAL
K900929 · Oculo Plastik, Inc. · May 1990
COX MALAR EMINENCE IMPLANTS
K900928 · Oculo Plastik, Inc. · May 1990
SPIVEY-ALLEN ORBITAL FLOOR IMPLANT
K900930 · Oculo Plastik, Inc. · May 1990
POREX(TM) EXTRA-OCULAR ORBITAL IMPLANT
K863946 · Porex Medical · Feb 1987
K900927 · CODERE-DURETTE ORBITAL FLOOR IMPLANT
Download PDF Oculo Plastik, Inc.