K-number	K193224
Device name	Daytona® Small Stature Growth Rod Conversion Set
Applicant	SeaSpine Orthopedics Corporation
Product code	PGM
Device class	Class II
Decision date	Feb 13, 2020
Decision	Substantially Equivalent
Regulation	888.3070

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Source

View the full FDA submission: accessdata.fda.gov

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Daytona® Small Stature Growth Rod Conversion Set

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