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FDA 510(k)

TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail System

K-Number: K240061 · 2024-09-20

ApplicantSmith & Nephew, Inc.
Decision Date2024-09-20
Product CodeJDS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail System is a medical device manufactured by Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2024-09-20 under approval number K240061. The device is classified under product code JDS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail System?

TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail System is a medical device that received FDA 510(k) clearance on 2024-09-20. It is manufactured by Smith & Nephew, Inc.. The 510(k) number is K240061.

When was TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail System approved by the FDA?

TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail System received FDA 510(k) clearance on 2024-09-20, under approval number K240061.

What company makes TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail System?

TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail System is manufactured by Smith & Nephew, Inc..

What is the FDA product code for TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail System?

The FDA product code for TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail System is JDS.

Related Clinical Trials

NCT07456865 Post Approval Effectiveness and Durability Evaluation of the Altaviva™ Tibial Device RECRUITING NCT06337292 Incisional Negative Pressure Wound Therapy to Reduce Infection and Complications in High-Risk Fractures RECRUITING NCT04358601 All-poly Versus Metal-backed ACTIVE_NOT_RECRUITING NCT03153475 ATTUNE Revision System in the Revision Total Knee Arthroplasty Population ACTIVE_NOT_RECRUITING NCT04389749 Continuous Passive Motion Following Fixation of Pelvic and Knee Fractures RECRUITING NCT03720782 Safety and Performance Study of the Legion Porous System in Total Knee Arthroplasty ACTIVE_NOT_RECRUITING

Other Devices by Smith & Nephew, Inc.

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Related Devices (Code: JDS)

K201336DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Screws Medullary Nails, 4.0 and 5.0mmSynthes (USA) Products, LLC K192003Auxein Nailing SystemAuxein Medical Private Limited K193533WIN Flexible Nail SystemBiomet, Inc. K230761TRIGEN META-NAIL Nail SystemSmith & Nephew, Inc. K241804TRIGEN INTERTAN 10S Nail SystemSmith & Nephew, Inc. K233150NET BRAND Osteosynthesis Nailing SystemNarang Medical , Ltd.

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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