510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K982562Substantially Equivalent

Bio-Eye Hydroxyapatite Ocular Impland and Conformer

Integrated Orbital Implants Inc, San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K982562 is the FDA 510(k) clearance record for BIO-EYE HYDROXYAPATITE OCULAR IMPLAND AND CONFORMER, a class II device, cleared for Integrated Orbital Implants, Inc. on under FDA product code HPZ (Implant, Eye Sphere). FDA records list 5 510(k) clearances for Integrated Orbital Implants, Inc., from to . As of , FDA records show 2 recalls naming K982562.

Clearance record

Decision date
Received
(158 days to decision)
Product code
HPZ Implant, Eye Sphere
Regulation
21 CFR 886.3320
Device class
Class II
Review panel
Ophthalmic
Applicant
Integrated Orbital Implants, Inc. 12526 High Bluff Dr., San Diego CA
510(k) summary
Summary
Third party review
No

Clearances, product code HPZ

Trailing 12 months

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

FDA records show no clearances under product code HPZ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HPZ, 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