510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K850631Substantially Equivalent

Kirschner Orthopedic Wire, Eyelet Cerclage Wires

Kirschner Medical Corp., Plymouth MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K850631 is the FDA 510(k) clearance record for KIRSCHNER ORTHOPEDIC WIRE, EYELET CERCLAGE WIRES, a class II device, cleared for Kirschner Medical Corp. on under FDA product code JDQ (Cerclage, Fixation). FDA records list 76 510(k) clearances for Kirschner Medical Corp., from to . As of , FDA records show no recalls naming K850631.

Clearance record

Decision date
Received
(71 days to decision)
Product code
JDQ Cerclage, Fixation
Regulation
21 CFR 888.3010
Device class
Class II
Review panel
Orthopedic
Applicant
Kirschner Medical Corp. Manager Pro Tem, Plymouth MN
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