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FDA 510(k)

PLUS ORTHOPEDICS CEMENTED HIP STEM

K-Number: K031165 · 2003-06-06

ApplicantPlus Orthopedics
Decision Date2003-06-06
Product CodeJDI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PLUS ORTHOPEDICS CEMENTED HIP STEM is the device name listed in this FDA 510(k) record. The listed applicant is Plus Orthopedics. It received FDA 510(k) clearance on 2003-06-06 under 510(k) number K031165. 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 PLUS ORTHOPEDICS CEMENTED HIP STEM?

PLUS ORTHOPEDICS CEMENTED HIP STEM is a medical device that received FDA 510(k) clearance on 2003-06-06. The listed applicant is Plus Orthopedics. The 510(k) number is K031165.

When did PLUS ORTHOPEDICS CEMENTED HIP STEM receive FDA 510(k) clearance?

PLUS ORTHOPEDICS CEMENTED HIP STEM received FDA 510(k) clearance on 2003-06-06, under 510(k) number K031165.

Who is the listed applicant for PLUS ORTHOPEDICS CEMENTED HIP STEM?

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

What is the FDA product code for PLUS ORTHOPEDICS CEMENTED HIP STEM?

The FDA product code for PLUS ORTHOPEDICS CEMENTED HIP STEM is JDI.

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Other records listing Plus Orthopedics 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.

K032126PROMOS SHOULDERK033763MODIFICATION TO SLIM GLIDING NAIL SYSTEMK032709MODULAR PLUS HIP STEMK032548IP-XS COMPRESSION NAIL SYSTEMK032215VKS/TC-PLUS REVISION KNEEK032052UC-PLUS SOLUTION UNICONDYLAR KNEE

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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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