510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K112111Substantially Equivalent

Acu-Sinch Repair System and Acumed Suture Anchor

Acumed LLC, Hillsboro OR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K112111 is the FDA 510(k) clearance record for ACU-SINCH REPAIR SYSTEM AND ACUMED SUTURE ANCHOR, a class II device, cleared for Acumed, LLC on under FDA product code HTN (Washer, Bolt Nut). FDA records list 38 510(k) clearances for Acumed, LLC, from to . As of , FDA records show no recalls naming K112111.

Clearance record

Decision date
Received
(112 days to decision)
Product code
HTN Washer, Bolt Nut
Regulation
21 CFR 888.3030
Device class
Class II
Review panel
Orthopedic
Applicant
Acumed, LLC 5885 NW Cornelius Pass Rd., Hillsboro OR
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