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FDA 510(k)

NEXFLEX TOTAL HIP SYSTEM

K-Number: K952629 · 1995-09-08

ApplicantNexmed, Inc.
Decision Date1995-09-08
Product CodeJDI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

NEXFLEX TOTAL HIP SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Nexmed, Inc.. It received FDA 510(k) clearance on 1995-09-08 under 510(k) number K952629. 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 NEXFLEX TOTAL HIP SYSTEM?

NEXFLEX TOTAL HIP SYSTEM is a medical device that received FDA 510(k) clearance on 1995-09-08. The listed applicant is Nexmed, Inc.. The 510(k) number is K952629.

When did NEXFLEX TOTAL HIP SYSTEM receive FDA 510(k) clearance?

NEXFLEX TOTAL HIP SYSTEM received FDA 510(k) clearance on 1995-09-08, under 510(k) number K952629.

Who is the listed applicant for NEXFLEX TOTAL HIP SYSTEM?

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

What is the FDA product code for NEXFLEX TOTAL HIP SYSTEM?

The FDA product code for NEXFLEX TOTAL HIP SYSTEM is JDI.

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Other records listing Nexmed, 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.

K033580NEXFLEX TOTAL HIP SYSTEMK991882NEXFLEX TOTAL KNEE SYSTEMK955170NEXFLEX FEMORAL STEM, STANDARD DESIGNK955171NEXLOCK FEMORAL STEMK951656NEXMED CANCELLOUS BONE SCREWS

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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