510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K110554Substantially Equivalent

Bioceramic Orbital Implant, Orbtex

Ceramisys Ltd, Centercille MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K110554 is the FDA 510(k) clearance record for BIOCERAMIC ORBITAL IMPLANT, ORBTEX, a class II device, cleared for Ceramisys, Ltd. on under FDA product code HPZ (Implant, Eye Sphere). FDA records list 2 510(k) clearances for Ceramisys, Ltd., from to . As of , FDA records show no recalls naming K110554.

Clearance record

Decision date
Received
(247 days to decision)
Product code
HPZ Implant, Eye Sphere
Regulation
21 CFR 886.3320
Device class
Class II
Review panel
Ophthalmic
Applicant
Ceramisys, Ltd. 344 Annabelle Pt. Rd., Centercille MA
510(k) summary
Statement
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