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510(k) K092530

SPRYTIE, MODELS ST001, ST002 AND ST003 by Russell B. Walther — Product Code DZK

K092530 is an FDA 510(k) premarket notification submitted by Russell B. Walther for the device "SPRYTIE, MODELS ST001, ST002 AND ST003". The FDA issued a decision of Substantially Equivalent on April 2, 2010. 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
April 2, 2010
Date Received
August 18, 2009
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

  • K022821 — ARAGON WIRING SYSTEM WIRE CARTRIDGE, MODELS I0007 WIRE CARTRIDGE, 22 GAUGE, I000 (November 15, 2002)

FDA data resources