510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K092530Substantially Equivalent

Sprytie, Models St001, St002 and St003

Russell B. Walther, Dallas TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K092530 is the FDA 510(k) clearance record for SPRYTIE, MODELS ST001, ST002 AND ST003, a class II device, cleared for Russell B. Walther on under FDA product code DZK (Wire, Fixation, Intraosseous). FDA records list one 510(k) clearance for Russell B. Walther. As of , FDA records show no recalls naming K092530.

Clearance record

Decision date
Received
(227 days to decision)
Product code
DZK Wire, Fixation, Intraosseous
Regulation
21 CFR 872.4880
Device class
Class II
Review panel
Dental
Applicant
Russell B. Walther 6026 Martel Ave., Dallas TX
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DZK

Trailing 12 months

FDA records hold no clearances under product code DZK in the trailing twelve months.

FDA records show no clearances under product code DZK in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DZK, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260