Name: Predicase
Price: 199 USD

K-number	K210716
Device name	CarboClear X Pedicle Screw System, CarboClear X Navigated Instruments
Applicant	CarboFix Orthopedics , Ltd.
Product code	NKB
Device class	Class II
Decision date	Apr 6, 2021
Decision	Substantially Equivalent
Regulation	888.3070

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Source

View the full FDA submission: accessdata.fda.gov

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CarboClear X Pedicle Screw System, CarboClear X Navigated Instruments

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