Name: Predicase
Price: 199 USD

K-number	K203002
Device name	SALGINA 2.5mm Volar Distal Radius System, CASCELLA 3.5mm Superior Clavicle System, TAMlNA 3.5mm Proximal Humerus System, TRIFT 3.5mm 1/3 Tubular System
Applicant	Bonebridge AG
Product code	HRS
Device class	Class II
Decision date	Oct 5, 2021
Decision	Substantially Equivalent
Regulation	888.3030

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Source

View the full FDA submission: accessdata.fda.gov

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SALGINA 2.5mm Volar Distal Radius System, CASCELLA 3.5mm Superior Clavicle System, TAMlNA 3.5mm Proximal Humerus System, TRIFT 3.5mm 1/3 Tubular System

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