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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 a medical device manufactured by I.T.S. GmbH. It received FDA 510(k) clearance on 2024-02-12 under approval 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. It is manufactured by I.T.S. GmbH. The 510(k) number is K233134.

When was I.T.S. INS Proximal Femur Nail approved by the FDA?

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

What company makes I.T.S. INS Proximal Femur Nail?

I.T.S. INS Proximal Femur Nail is manufactured by I.T.S. GmbH.

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.

Related Clinical Trials

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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.