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FDA 510(k)

ODI TALON LONG PROXIMAL FEMORAL NAIL SYSTEM

K-Number: K033286 · 2004-01-12

ApplicantOrthopedic Designs, Inc. (Odi)
Decision Date2004-01-12
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ODI TALON LONG PROXIMAL FEMORAL NAIL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Orthopedic Designs, Inc. (Odi). It received FDA 510(k) clearance on 2004-01-12 under 510(k) number K033286. 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 ODI TALON LONG PROXIMAL FEMORAL NAIL SYSTEM?

ODI TALON LONG PROXIMAL FEMORAL NAIL SYSTEM is a medical device that received FDA 510(k) clearance on 2004-01-12. The listed applicant is Orthopedic Designs, Inc. (Odi). The 510(k) number is K033286.

When did ODI TALON LONG PROXIMAL FEMORAL NAIL SYSTEM receive FDA 510(k) clearance?

ODI TALON LONG PROXIMAL FEMORAL NAIL SYSTEM received FDA 510(k) clearance on 2004-01-12, under 510(k) number K033286.

Who is the listed applicant for ODI TALON LONG PROXIMAL FEMORAL NAIL SYSTEM?

The FDA 510(k) record lists Orthopedic Designs, Inc. (Odi) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ODI TALON LONG PROXIMAL FEMORAL NAIL SYSTEM?

The FDA product code for ODI TALON LONG PROXIMAL FEMORAL NAIL SYSTEM is HSB.

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Related Devices (Code: HSB)

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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.

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