Name: Predicase
Price: 199 USD

K-number	K240137
Device name	Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System
Applicant	Neos Surgery S.L
Product code	GXR
Device class	Class II
Decision date	Feb 16, 2024
Decision	Substantially Equivalent
Regulation	882.5250

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System

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