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FDA 510(k)

IMPLEX H-110 AND H-120 CEMENTED HIP STEM SYSTEM

K-Number: K925348 · 1993-05-12

ApplicantImplex Corp.
Decision Date1993-05-12
Product CodeJDI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

IMPLEX H-110 AND H-120 CEMENTED HIP STEM SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Implex Corp.. It received FDA 510(k) clearance on 1993-05-12 under 510(k) number K925348. 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 IMPLEX H-110 AND H-120 CEMENTED HIP STEM SYSTEM?

IMPLEX H-110 AND H-120 CEMENTED HIP STEM SYSTEM is a medical device that received FDA 510(k) clearance on 1993-05-12. The listed applicant is Implex Corp.. The 510(k) number is K925348.

When did IMPLEX H-110 AND H-120 CEMENTED HIP STEM SYSTEM receive FDA 510(k) clearance?

IMPLEX H-110 AND H-120 CEMENTED HIP STEM SYSTEM received FDA 510(k) clearance on 1993-05-12, under 510(k) number K925348.

Who is the listed applicant for IMPLEX H-110 AND H-120 CEMENTED HIP STEM SYSTEM?

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

What is the FDA product code for IMPLEX H-110 AND H-120 CEMENTED HIP STEM SYSTEM?

The FDA product code for IMPLEX H-110 AND H-120 CEMENTED HIP STEM SYSTEM is JDI.

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Other records listing Implex Corp. 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.

K051978TRABECULAR METAL VERTEBRAL BODY REPLACEMENTK051196TRABECULAR METAL VERTEBRAL BODY REPLACEMENT, MODEL 06-165-011X1 AND 06-166-051X1K040487TRABECULAR METAL KNEE SYSTEM AUGMENTSK040630TRABECULAR METAL FEMORAL CONE AUGMENTS, MODEL 03-125-ZZZZK040756THE TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 10-340-XXXXXK031962NEXGEN TRABECULAR METAL TIBIAL CONE AUGMENTS

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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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