Name: Predicase
Price: 199 USD

K-number	K211695
Device name	Valkyrie Thoracic Fixation System
Applicant	Jm Longyear Manufacturing, LLC D/B/A Able Medical Devices
Product code	HRS
Device class	Class II
Decision date	Jun 23, 2021
Decision	Substantially Equivalent
Regulation	888.3030

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Source

View the full FDA submission: accessdata.fda.gov

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Valkyrie Thoracic Fixation System

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