DePuy Synthes 3.5mm Intrapelvic Acetabular System
K-Number: K221809 · 2022-09-20
ApplicantDePuy Synthes
Decision Date2022-09-20
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
DePuy Synthes 3.5mm Intrapelvic Acetabular System is a medical device manufactured by DePuy Synthes. It received FDA 510(k) clearance on 2022-09-20 under approval number K221809. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the DePuy Synthes 3.5mm Intrapelvic Acetabular System?
DePuy Synthes 3.5mm Intrapelvic Acetabular System is a medical device that received FDA 510(k) clearance on 2022-09-20. It is manufactured by DePuy Synthes. The 510(k) number is K221809.
When was DePuy Synthes 3.5mm Intrapelvic Acetabular System approved by the FDA?
DePuy Synthes 3.5mm Intrapelvic Acetabular System received FDA 510(k) clearance on 2022-09-20, under approval number K221809.
What company makes DePuy Synthes 3.5mm Intrapelvic Acetabular System?
DePuy Synthes 3.5mm Intrapelvic Acetabular System is manufactured by DePuy Synthes.
What is the FDA product code for DePuy Synthes 3.5mm Intrapelvic Acetabular System?
The FDA product code for DePuy Synthes 3.5mm Intrapelvic Acetabular System is HRS.
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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.