510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K012125Substantially Equivalent

Opus Magnum Anchor & Inserter

Opus Medical, Inc., San Juan Capistrano CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K012125 is the FDA 510(k) clearance record for OPUS MAGNUM ANCHOR & INSERTER, a class II device, cleared for Opus Medical, Inc. on under FDA product code HTY (Pin, Fixation, Smooth). FDA records list 13 510(k) clearances for Opus Medical, Inc., from to . As of , FDA records show no recalls naming K012125.

Clearance record

Decision date
Received
(73 days to decision)
Product code
HTY Pin, Fixation, Smooth
Regulation
21 CFR 888.3040
Device class
Class II
Review panel
Orthopedic
Applicant
Opus Medical, Inc. 27127 Calle Arroyo, Suite 1924, San Juan Capistrano CA
510(k) summary
Statement
Third party review
No

Clearances, product code HTY

Trailing 12 months
2 clearances under product code HTY in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code HTY, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260