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FDA 510(k)

HSS FEMORAL COMPONENTS

K-Number: K934857 · 1995-07-18

ApplicantHospital For Special Surgery
Decision Date1995-07-18
Product CodeJDI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HSS FEMORAL COMPONENTS is the device name listed in this FDA 510(k) record. The listed applicant is Hospital For Special Surgery. It received FDA 510(k) clearance on 1995-07-18 under 510(k) number K934857. 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 HSS FEMORAL COMPONENTS?

HSS FEMORAL COMPONENTS is a medical device that received FDA 510(k) clearance on 1995-07-18. The listed applicant is Hospital For Special Surgery. The 510(k) number is K934857.

When did HSS FEMORAL COMPONENTS receive FDA 510(k) clearance?

HSS FEMORAL COMPONENTS received FDA 510(k) clearance on 1995-07-18, under 510(k) number K934857.

Who is the listed applicant for HSS FEMORAL COMPONENTS?

The FDA 510(k) record lists Hospital For Special Surgery as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HSS FEMORAL COMPONENTS?

The FDA product code for HSS FEMORAL COMPONENTS is JDI.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Hospital For Special Surgery 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.

K942032PLAMP, PLAMP PLATE, PLAMP WITH HOOKK935080INSALL-BURSTEIN II

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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