510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K212594Substantially Equivalent

OSSIOfiber® Staple

OSSIO, Ltd., Caesarea, IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K212594 is the FDA 510(k) clearance record for OSSIOfiber® Staple, a class II device, cleared for OSSIO , Ltd. on under FDA product code MNU (Staple, Absorbable). FDA records list 20 510(k) clearances for OSSIO , Ltd., from to . As of , FDA records show no recalls naming K212594.

Clearance record

Decision date
Received
(158 days to decision)
Product code
MNU Staple, Absorbable
Regulation
21 CFR 888.3030
Device class
Class II
Review panel
Orthopedic
Applicant
OSSIO , Ltd. 8 Hatochen St., Caesarea, IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MNU

Trailing 12 months

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

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