510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K163226Substantially Equivalent

EPIC Extremely Small Staple

Epic Extremely, LLC, Cranberry Twp PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K163226 is the FDA 510(k) clearance record for EPIC Extremely Small Staple, a class II device, cleared for Epic Extremely, LLC on under FDA product code JDR (Staple, Fixation, Bone). FDA records list one 510(k) clearance for Epic Extremely, LLC. As of , FDA records show no recalls naming K163226.

Clearance record

Decision date
Received
(180 days to decision)
Product code
JDR Staple, Fixation, Bone
Regulation
21 CFR 888.3030
Device class
Class II
Review panel
Orthopedic
Applicant
Epic Extremely, LLC 120 Marguerite Dr., Suite 301, Cranberry Twp PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JDR

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