510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K900927Substantially Equivalent

Codere-Durette Orbital Floor Implant

Oculo Plastik, Inc., Montreal, Quebec Canada, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K900927 is the FDA 510(k) clearance record for CODERE-DURETTE ORBITAL FLOOR IMPLANT, a class II device, cleared for Oculo Plastik, Inc. on under FDA product code HQX (Implant, Orbital, Extra-Ocular). FDA records list 13 510(k) clearances for Oculo Plastik, Inc., from to . As of , FDA records show no recalls naming K900927.

Clearance record

Decision date
Received
(77 days to decision)
Product code
HQX Implant, Orbital, Extra-Ocular
Regulation
21 CFR 886.3340
Device class
Class II
Review panel
Ophthalmic
Applicant
Oculo Plastik, Inc. 1170 E., Montreal, Quebec Canada, CA
Third party review
No

Clearances, product code HQX

Trailing 12 months

FDA records hold no clearances under product code HQX in the trailing twelve months.

FDA records show no clearances under product code HQX in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HQX, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260