510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K946346Substantially Equivalent

Acufex Tag(r) Bioabsorbable Anchors

Acufex Microsurgical, Inc., Mansfield MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K946346 is the FDA 510(k) clearance record for ACUFEX TAG(R) BIOABSORBABLE ANCHORS, a class II device, cleared for Acufex Microsurgical, Inc. on under FDA product code JDR (Staple, Fixation, Bone). FDA records list 78 510(k) clearances for Acufex Microsurgical, Inc., from to . As of , FDA records show no recalls naming K946346.

Clearance record

Decision date
Received
(117 days to decision)
Product code
JDR Staple, Fixation, Bone
Regulation
21 CFR 888.3030
Device class
Class II
Review panel
Orthopedic
Applicant
Acufex Microsurgical, Inc. 130 Forbes Blvd., Mansfield MA
510(k) summary
Statement
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