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FDA 510(k)

Platform® Acetabular System

K-Number: K220483 · 2022-09-23

ApplicantTotal Joint Orthopedics, Inc.
Decision Date2022-09-23
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Platform® Acetabular System is the device name listed in this FDA 510(k) record. The listed applicant is Total Joint Orthopedics, Inc.. It received FDA 510(k) clearance on 2022-09-23 under 510(k) number K220483. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Platform® Acetabular System?

Platform® Acetabular System is a medical device that received FDA 510(k) clearance on 2022-09-23. The listed applicant is Total Joint Orthopedics, Inc.. The 510(k) number is K220483.

When did Platform® Acetabular System receive FDA 510(k) clearance?

Platform® Acetabular System received FDA 510(k) clearance on 2022-09-23, under 510(k) number K220483.

Who is the listed applicant for Platform® Acetabular System?

The FDA 510(k) record lists Total Joint Orthopedics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Platform® Acetabular System?

The FDA product code for Platform® Acetabular System is LZO.

Other records listing Total Joint Orthopedics, Inc. as applicant

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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Related Devices (Code: LZO)

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.

K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KGK260831Z1 Hip SystemZimmer, Inc.K260182Avenir® Müller Stem; Avenir Complete™ Hip SystemZimmer, Inc.K260037implantcast Packaging System UpdateImplantcast GmbHK252401implaFit® short stemsImplantcast GmbHK253171Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)Maxx Orthopedics, Inc.

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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