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FDA 510(k)

EUROSTEM HIP PROTHESIS SYSTEM

K-Number: K922863 · 1993-02-12

ApplicantOsteo Technology, Inc.
Decision Date1993-02-12
Product CodeJDI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EUROSTEM HIP PROTHESIS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Osteo Technology, Inc.. It received FDA 510(k) clearance on 1993-02-12 under 510(k) number K922863. 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 EUROSTEM HIP PROTHESIS SYSTEM?

EUROSTEM HIP PROTHESIS SYSTEM is a medical device that received FDA 510(k) clearance on 1993-02-12. The listed applicant is Osteo Technology, Inc.. The 510(k) number is K922863.

When did EUROSTEM HIP PROTHESIS SYSTEM receive FDA 510(k) clearance?

EUROSTEM HIP PROTHESIS SYSTEM received FDA 510(k) clearance on 1993-02-12, under 510(k) number K922863.

Who is the listed applicant for EUROSTEM HIP PROTHESIS SYSTEM?

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

What is the FDA product code for EUROSTEM HIP PROTHESIS SYSTEM?

The FDA product code for EUROSTEM HIP PROTHESIS SYSTEM is JDI.

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Other records listing Osteo Technology, 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.

K926156REPLICA(TM) TOTAL HIP SYSTEMK922859ANATOMICAL TYPE KNEE SYSTEMK922869TOTAL CONDYLAT TYPE KNEE SYSTEMK925447OTI ORTHOPEDIC WIRE SYSTEMK926213MODIFIED ZICKEL INTRAMEDULLARY ROD SYSTEMK922861BIOMETRIC SCREW FIXATION CUP

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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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