Name: Predicase
Price: 199 USD

K-number	K201253
Device name	Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator, ILIZAROV External Fixator, Other External Fixation
Applicant	Smith & Nephew
Product code	KTT
Device class	Class II
Decision date	Dec 8, 2020
Decision	Substantially Equivalent
Regulation	888.3030

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Source

View the full FDA submission: accessdata.fda.gov

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Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator, ILIZAROV External Fixator, Other External Fixation

Everything you need for a 510(k) submission. Nothing you don't.