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510(k) K022821

ARAGON WIRING SYSTEM WIRE CARTRIDGE, MODELS I0007 WIRE CARTRIDGE, 22 GAUGE, I0008 WIRE CARTRIDGE, 24 GAUGE, I0009 WIRE E by Ideatrics, Inc. — Product Code DZK

K022821 is an FDA 510(k) premarket notification submitted by Ideatrics, Inc. for the device "ARAGON WIRING SYSTEM WIRE CARTRIDGE, MODELS I0007 WIRE CARTRIDGE, 22 GAUGE, I0008 WIRE CARTRIDGE, 24 GAUGE, I0009 WIRE E". The FDA issued a decision of Substantially Equivalent on November 15, 2002. The device falls under product code DZK (Wire, Fixation, Intraosseous), a Class II device regulated under 21 CFR 872.4880.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 15, 2002
Date Received
August 26, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wire, Fixation, Intraosseous
Device Class
Class II
Regulation Number
872.4880
Review Panel
DE
Submission Type

Other clearances for product code DZK

  • K092530 — SPRYTIE, MODELS ST001, ST002 AND ST003 (April 2, 2010)

FDA data resources