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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is DePuy Synthes. It received FDA 510(k) clearance on 2022-09-20 under 510(k) 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. The listed applicant is DePuy Synthes. The 510(k) number is K221809.

When did DePuy Synthes 3.5mm Intrapelvic Acetabular System receive FDA 510(k) clearance?

DePuy Synthes 3.5mm Intrapelvic Acetabular System received FDA 510(k) clearance on 2022-09-20, under 510(k) number K221809.

Who is the listed applicant for DePuy Synthes 3.5mm Intrapelvic Acetabular System?

The FDA 510(k) record lists DePuy Synthes as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing DePuy Synthes as applicant

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Related Devices (Code: HRS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.

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