510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K043145Substantially Equivalent

Bi-Cortical Bio-Post and Washer, Model Ar-1367B

Arthrex GmbH, Naples FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K043145 is the FDA 510(k) clearance record for BI-CORTICAL BIO-POST AND WASHER, MODEL AR-1367B, a class II device, cleared for Arthrex, Inc. on under FDA product code HTN (Washer, Bolt Nut). FDA records list 352 510(k) clearances for Arthrex, Inc., from to . As of , FDA records show one recall naming K043145.

Clearance record

Decision date
Received
(95 days to decision)
Product code
HTN Washer, Bolt Nut
Regulation
21 CFR 888.3030
Device class
Class II
Review panel
Orthopedic
Applicant
Arthrex, Inc. 1370 Creekside Blvd., Naples FL
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