Name: Predicase
Price: 199 USD

K-number	K203673
Device name	MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC and Drill Pilot Guides, and MySpine S2-Alar/Alar Iliac Guides)
Applicant	Medacta International S.A.
Product code	PQC
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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MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC and Drill Pilot Guides, and MySpine S2-Alar/Alar Iliac Guides)

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