Biocore9 Acetabular Cup System
K-Number: K212761 · 2022-05-17
ApplicantBiocore9, LLC
Decision Date2022-05-17
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Biocore9 Acetabular Cup System is a medical device manufactured by Biocore9, LLC. It received FDA 510(k) clearance on 2022-05-17 under approval number K212761. The device is classified under product code LPH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Biocore9 Acetabular Cup System?
Biocore9 Acetabular Cup System is a medical device that received FDA 510(k) clearance on 2022-05-17. It is manufactured by Biocore9, LLC. The 510(k) number is K212761.
When was Biocore9 Acetabular Cup System approved by the FDA?
Biocore9 Acetabular Cup System received FDA 510(k) clearance on 2022-05-17, under approval number K212761.
What company makes Biocore9 Acetabular Cup System?
Biocore9 Acetabular Cup System is manufactured by Biocore9, LLC.
What is the FDA product code for Biocore9 Acetabular Cup System?
The FDA product code for Biocore9 Acetabular Cup System is LPH.
Related Clinical Trials
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.