510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K960651Substantially Equivalent

Cerclage Wire Crimp Block

Acu Med, Inc., Beaveton OR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K960651 is the FDA 510(k) clearance record for CERCLAGE WIRE CRIMP BLOCK, a class II device, cleared for Acu-Med, Inc. on under FDA product code JDQ (Cerclage, Fixation). FDA records list 48 510(k) clearances for Acu-Med, Inc., from to . As of , FDA records show no recalls naming K960651.

Clearance record

Decision date
Received
(78 days to decision)
Product code
JDQ Cerclage, Fixation
Regulation
21 CFR 888.3010
Device class
Class II
Review panel
Orthopedic
Applicant
Acu-Med, Inc. 10950 SW 5th, Suite 170, Beaveton OR
510(k) summary
Summary
Third party review
No

Clearances, product code JDQ

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