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FDA 510(k)

Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing System

K-Number: K213328 · 2022-02-11

ApplicantStryker GmbH
Decision Date2022-02-11
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing System is a medical device manufactured by Stryker GmbH. It received FDA 510(k) clearance on 2022-02-11 under approval number K213328. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing System?

Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing System is a medical device that received FDA 510(k) clearance on 2022-02-11. It is manufactured by Stryker GmbH. The 510(k) number is K213328.

When was Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing System approved by the FDA?

Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing System received FDA 510(k) clearance on 2022-02-11, under approval number K213328.

What company makes Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing System?

Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing System is manufactured by Stryker GmbH.

What is the FDA product code for Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing System?

The FDA product code for Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing System is HSB.

Related Clinical Trials

NCT07456865 Post Approval Effectiveness and Durability Evaluation of the Altaviva™ Tibial Device RECRUITING NCT04358601 All-poly Versus Metal-backed ACTIVE_NOT_RECRUITING NCT03153475 ATTUNE Revision System in the Revision Total Knee Arthroplasty Population ACTIVE_NOT_RECRUITING NCT03720782 Safety and Performance Study of the Legion Porous System in Total Knee Arthroplasty ACTIVE_NOT_RECRUITING NCT05565131 Performance Measurement and Safety Evaluation of the PYTHEAS® ODYSSEE Angular Assistance System for Intra-pedicular Screw Placement in Adult Spine Surgery COMPLETED NCT04015128 A Post-Market Clinical Evaluation of the Treatment of Femur Fractures With the Femoral Nail GT ACTIVE_NOT_RECRUITING

Other Devices by Stryker GmbH

K161863ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA), ReUnion Total Shoulder Arthroplasty (TSA) K161753Hoffman LRF System K160813EasyStep K153379AxSOS 3Ti K153377Hoffmann LRF (Limb Reconstruction Frame) System K172350AxSOS 3 Ti

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Related Devices (Code: HSB)

K161264TRIGEN Low Profile Bone ScrewsSmith & Nephew, Inc. K160545GAP ENDO-EXO MEDULLARY SYSTEMPega Medical, Inc. K161254Renovo Life Small Bone IM Nail SystemRenovo Life, LLC K160167DePuy Synthes TFNA Augmentation SystemSynthes (USA) Products, LLC K160325PRECICE Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. K160267PRECICE Trauma Nail SystemEllipse Technologies, Incorporated

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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