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FDA 510(k)

I.T.S. INS Proximal Femur Nail

K-Number: K233134 · 2024-02-12

ApplicantI.T.S. GmbH
Decision Date2024-02-12
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

I.T.S. INS Proximal Femur Nail is the device name listed in this FDA 510(k) record. The listed applicant is I.T.S. GmbH. It received FDA 510(k) clearance on 2024-02-12 under 510(k) number K233134. 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 I.T.S. INS Proximal Femur Nail?

I.T.S. INS Proximal Femur Nail is a medical device that received FDA 510(k) clearance on 2024-02-12. The listed applicant is I.T.S. GmbH. The 510(k) number is K233134.

When did I.T.S. INS Proximal Femur Nail receive FDA 510(k) clearance?

I.T.S. INS Proximal Femur Nail received FDA 510(k) clearance on 2024-02-12, under 510(k) number K233134.

Who is the listed applicant for I.T.S. INS Proximal Femur Nail?

The FDA 510(k) record lists I.T.S. GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for I.T.S. INS Proximal Femur Nail?

The FDA product code for I.T.S. INS Proximal Femur Nail is HSB.

Other records listing I.T.S. GmbH 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.

K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular Stability; I.T.S. Humeral Head Plate with Angular Stability; I.T.S. FR.O.H. Calcaneus Repair System; I.T.S. Pilonplate with Angular Stability; I.T.S. Olecranonplate with Angular Stability; I.T.S. Straight Plate with Angular Stability; I.T.S. Screw System; I.T.S. PRS Sacral Rod System; I.T.S. Fibula Plate PROlock with Angular Stability; I.T.S. Distal Humeral Plates with Angular Stability; I.T.S. LRS (LK260054I.T.S. PRS Phoenix IIK210935I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)

Related Devices (Code: HSB)

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.

K261481Pangea Femur Reconstruction SystemStryker GmbHK261651Precice™ Max System and Precice™ Ankle Salvage SystemNuVasive Specialized OrthopedicsK253080AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)Suzhou and Science & Technology Development Corp.K253155Fule Metallic Lockable Intramedullary Nail SystemsBeijing Fule Science & Technology Development Co., Ltd.K253046HERA Interlocking Intramedullary Nailing SystemZheJiang Decans Medical Devices Co., Ltd.K260146FITBONE® TRANSPORT AND LENGTHENING SYSTEMOrthofix Srl

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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