FDA 510(k)

LFIT V40 FEMORAL HEAD COMPONENTS

K-Number: K010757 · 2001-04-11

Decision Date2001-04-11

Product CodeJDI

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

LFIT V40 FEMORAL HEAD COMPONENTS is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Osteonics Corp.. It received FDA 510(k) clearance on 2001-04-11 under 510(k) number K010757. 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 LFIT V40 FEMORAL HEAD COMPONENTS?

LFIT V40 FEMORAL HEAD COMPONENTS is a medical device that received FDA 510(k) clearance on 2001-04-11. The listed applicant is Howmedica Osteonics Corp.. The 510(k) number is K010757.

When did LFIT V40 FEMORAL HEAD COMPONENTS receive FDA 510(k) clearance?

LFIT V40 FEMORAL HEAD COMPONENTS received FDA 510(k) clearance on 2001-04-11, under 510(k) number K010757.

Who is the listed applicant for LFIT V40 FEMORAL HEAD COMPONENTS?

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

What is the FDA product code for LFIT V40 FEMORAL HEAD COMPONENTS?

The FDA product code for LFIT V40 FEMORAL HEAD 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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Howmedica Osteonics Corp. as applicant

K193429Exeter V40 Femoral Stem, Exeter X3 RimFit Cup K200782Triathlon Posterior Stabilized Femoral Component - beaded with Peri-Apatite, Triathlon Cruciate Retaining Femoral Component - beaded with Peri-Apatite K130895REUNION RSA SHOULDER SYSTEM K123604ABG III MONOLITHIC HIP STEM K122015DISTAL FEMORAL GROWING PROSTHESIS, TIBIAL ROTATING COMPONENTS, BEARING, AXIS, CIRCLIP, WEDGE K123166TRIATHLON ALL-POLYETHYLENE CONDYLAR STABILIZING (CS) TIBIAL IMPLANTS TRIATHLON ALL-POLYETHYLENE POSTERIOR STABILIZING (P

View all 288 devices →

Related Devices (Code: JDI)

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 Biomet K240783Anthology 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 Orthopaedics K240418Stryker 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.