510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K923776Substantially Equivalent

Benderev Drill Guide

Neimark Labs, Inc., Mission Viejo CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K923776 is the FDA 510(k) clearance record for BENDEREV DRILL GUIDE, a class I device, cleared for Neimark Labs, Inc. on under FDA product code HXY (Brace, Drill). FDA records list 2 510(k) clearances for Neimark Labs, Inc., from to . As of , FDA records show no recalls naming K923776.

Clearance record

Decision date
Received
(101 days to decision)
Product code
HXY Brace, Drill
Regulation
21 CFR 888.4540
Device class
Class I
Review panel
Orthopedic
Applicant
Neimark Labs, Inc. 26732 Crown Valley, 501, Mission Viejo CA
510(k) summary
Statement
Third party review
No

Clearances, product code HXY

Trailing 12 months

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

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