510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K890641Substantially Equivalent

Acufex Cannulated Screws, Washers, Bone Plates

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

K890641 is the FDA 510(k) clearance record for ACUFEX CANNULATED SCREWS, WASHERS, BONE PLATES, a class II device, cleared for Acufex Microsurgical, Inc. on under FDA product code HRS (Plate, Fixation, Bone). FDA records list 78 510(k) clearances for Acufex Microsurgical, Inc., from to . As of , FDA records show no recalls naming K890641.

Clearance record

Decision date
Received
(19 days to decision)
Product code
HRS Plate, Fixation, Bone
Regulation
21 CFR 888.3030
Device class
Class II
Review panel
Orthopedic
Applicant
Acufex Microsurgical, Inc. 575 University Ave., Norwood MA
Third party review
No

Clearances, product code HRS

Trailing 12 months
60 clearances under product code HRS in the twelve months to October 2026, March 2026 the highest month at 13.
Show the numbers
Monthly 510(k) clearances under FDA product code HRS, trailing twelve months
MonthClearances
November 20255
December 20255
January 20264
February 20265
March 202613
April 20266
May 20262
June 20265
July 20265
August 20263
September 20265
October 20262