Name: Predicase
Price: 199 USD

K-number	K234025
Device name	22.2mm BIOLOX® delta Ceramic V40 Femoral Heads
Applicant	Howmedica Osteonics Corp., Dba Stryker Orthopaedics
Product code	LZO
Device class	Class II
Decision date	Apr 24, 2024
Decision	Substantially Equivalent
Regulation	888.3353

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Source

View the full FDA submission: accessdata.fda.gov

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22.2mm BIOLOX® delta Ceramic V40 Femoral Heads

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

22.2mm BIOLOX® delta Ceramic V40 Femoral Heads