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Siberian Fit

Vydence

Country / region:Brazil (BR)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Company

Vydence
Brazil (BR)

Product code

GEX
21 CFR 878.4810

Predicate devices

0
Cited in this 510(k)

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K172439
Device name
Siberian Fit
Company
Vydence
Country / region
Brazil(BR)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2017-08-11
Decision date
2018-02-14
Submission type
Traditional
Technology type
Other(AI inferred)
Clinical applications
Surgical cutting
Primary application
Surgical cutting
Classification source
AI classified

Intended Use

e
enclosure) to legally marketed

Summary parsed at:2026-06-01 05:56:23 UTC

Predicate devices

0

No predicate K numbers were extracted

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Cited as predicate

0

No later 510(k)s cite this device yet

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