510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K103797Substantially Equivalent

K2m Cocr Wire

K2M, Inc, Leesburg VA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K103797 is the FDA 510(k) clearance record for K2M COCR WIRE, a class II device, cleared for K2m, Inc. on under FDA product code JDQ (Cerclage, Fixation). FDA records list 123 510(k) clearances for K2m, Inc., from to . As of , FDA records show no recalls naming K103797.

Clearance record

Decision date
Received
(144 days to decision)
Product code
JDQ Cerclage, Fixation
Regulation
21 CFR 888.3010
Device class
Class II
Review panel
Orthopedic
Applicant
K2m, Inc. 751 Miller Dr. SE, Leesburg VA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JDQ

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