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FDA 510(k)

RX 90 FEMORAL STEM AND RX 90 LATERALIZED FEMORAL STEM

K-Number: K023085 · 2002-10-17

ApplicantBiomet Orthopedics, Inc.
Decision Date2002-10-17
Product CodeJDI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

RX 90 FEMORAL STEM AND RX 90 LATERALIZED FEMORAL STEM is the device name listed in this FDA 510(k) record. The listed applicant is Biomet Orthopedics, Inc.. It received FDA 510(k) clearance on 2002-10-17 under 510(k) number K023085. The device is classified under product code JDI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RX 90 FEMORAL STEM AND RX 90 LATERALIZED FEMORAL STEM?

RX 90 FEMORAL STEM AND RX 90 LATERALIZED FEMORAL STEM is a medical device that received FDA 510(k) clearance on 2002-10-17. The listed applicant is Biomet Orthopedics, Inc.. The 510(k) number is K023085.

When did RX 90 FEMORAL STEM AND RX 90 LATERALIZED FEMORAL STEM receive FDA 510(k) clearance?

RX 90 FEMORAL STEM AND RX 90 LATERALIZED FEMORAL STEM received FDA 510(k) clearance on 2002-10-17, under 510(k) number K023085.

Who is the listed applicant for RX 90 FEMORAL STEM AND RX 90 LATERALIZED FEMORAL STEM?

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

What is the FDA product code for RX 90 FEMORAL STEM AND RX 90 LATERALIZED FEMORAL STEM?

The FDA product code for RX 90 FEMORAL STEM AND RX 90 LATERALIZED FEMORAL STEM is JDI.

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Other records listing Biomet 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.

K253515Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and AugmentsK080528E-POLY TIBIAL BEARINGSK072879INNERVUE DIAGNOSTIC SCOPE SYSTEMK070955ACID ETCHED LAG SCREWSK033355LACTOSCREW SCREW ANCHORK032286CALCIGEN PSI BONE GRAFT SUBSTITUTE

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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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