Name: Predicase
Price: 199 USD

K-number	K213580
Device name	Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head length
Applicant	Total Joint Othopedics, Inc.
Product code	LZO
Device class	Class II
Decision date	Dec 3, 2021
Decision	Substantially Equivalent
Regulation	888.3353

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Source

View the full FDA submission: accessdata.fda.gov

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Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head length

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