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FDA 510(k)

DOMED AND FINNED ACETABULAR COMPONENT

K-Number: K901328 · 1990-05-22

ApplicantOrthomet, Inc.
Decision Date1990-05-22
Product CodeJDI
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

DOMED AND FINNED ACETABULAR COMPONENT is the device name listed in this FDA 510(k) record. The listed applicant is Orthomet, Inc.. It received FDA 510(k) clearance on 1990-05-22 under 510(k) number K901328. The device is classified under product code JDI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the DOMED AND FINNED ACETABULAR COMPONENT?

DOMED AND FINNED ACETABULAR COMPONENT is a medical device that received FDA 510(k) clearance on 1990-05-22. The listed applicant is Orthomet, Inc.. The 510(k) number is K901328.

When did DOMED AND FINNED ACETABULAR COMPONENT receive FDA 510(k) clearance?

DOMED AND FINNED ACETABULAR COMPONENT received FDA 510(k) clearance on 1990-05-22, under 510(k) number K901328.

Who is the listed applicant for DOMED AND FINNED ACETABULAR COMPONENT?

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

What is the FDA product code for DOMED AND FINNED ACETABULAR COMPONENT?

The FDA product code for DOMED AND FINNED ACETABULAR COMPONENT is JDI.

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Other records listing Orthomet, Inc. as applicant

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Related Devices (Code: JDI)

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.

K253515Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and AugmentsBiomet Orthopedics, Inc.K253434OSSTM Orthopedic Salvage SystemBiomet, Inc.K243571Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained LinersZimmer BiometK240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip StemsSmith & Nephew, Inc.K241716Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee ComponentHowmedica Osteonics Corp., Dba Stryker OrthopaedicsK240418Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics

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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