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
K083342Substantially Equivalent

Orbital Reconstructive Implant II

Evera Medical, Inc., Foster City CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K083342 is the FDA 510(k) clearance record for ORBITAL RECONSTRUCTIVE IMPLANT II, a class II device, cleared for Evera Medical, Inc. on under FDA product code HPZ (Implant, Eye Sphere). FDA records list 2 510(k) clearances for Evera Medical, Inc., from to . As of , FDA records show no recalls naming K083342.

Clearance record

Decision date
Received
(120 days to decision)
Product code
HPZ Implant, Eye Sphere
Regulation
21 CFR 886.3320
Device class
Class II
Review panel
Ophthalmic
Applicant
Evera Medical, Inc. 353 Vintage Park Dr., Foster City CA
510(k) summary
Summary PDF
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