510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K153211Substantially Equivalent

M-Fix Acromioclavicular Device

Coracoid Solutions, Inc., Park City UT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K153211 is the FDA 510(k) clearance record for M-Fix Acromioclavicular Device, a class II device, cleared for Coracoid Solutions, Inc. on under FDA product code HTN (Washer, Bolt Nut). FDA records list one 510(k) clearance for Coracoid Solutions, Inc. As of , FDA records show no recalls naming K153211.

Clearance record

Decision date
Received
(89 days to decision)
Product code
HTN Washer, Bolt Nut
Regulation
21 CFR 888.3030
Device class
Class II
Review panel
Orthopedic
Applicant
Coracoid Solutions, Inc. 15 Normans Way, Park City UT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HTN

Trailing 12 months
3 clearances under product code HTN 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 HTN, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20261
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260