Name: Predicase
Price: 199 USD

K-number	K222632
Device name	UHR Bipolar Implants, Restoration GAP II Implants
Applicant	Howmedica Osteonics Corp., Dba Stryker Orthopaedics
Product code	KWL
Device class	Class II
Decision date	Oct 21, 2022
Decision	Substantially Equivalent
Regulation	888.3360

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Source

View the full FDA submission: accessdata.fda.gov

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UHR Bipolar Implants, Restoration GAP II Implants

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