510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K070130Substantially Equivalent

Orbital Reconstructive Implant

Becker & Associates Consulting, Inc., Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K070130 is the FDA 510(k) clearance record for ORBITAL RECONSTRUCTIVE IMPLANT, a class II device, cleared for Becker & Associates Consulting, Inc. on under FDA product code HPZ (Implant, Eye Sphere). FDA records list one 510(k) clearance for Becker & Associates Consulting, Inc. As of , FDA records show no recalls naming K070130.

Clearance record

Decision date
Received
(93 days to decision)
Product code
HPZ Implant, Eye Sphere
Regulation
21 CFR 886.3320
Device class
Class II
Review panel
Ophthalmic
Applicant
Becker & Associates Consulting, Inc. 2001 Pennsylvania Ave. NW, Suite 950, Washington DC
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