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FDA 510(k)

2.4 SMARTNAIL, MODELS 532416, 532425, 532435, 532445

K-Number: K031981 · 2003-07-25

ApplicantLinvatec Biomaterials, Ltd.
Decision Date2003-07-25
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

2.4 SMARTNAIL, MODELS 532416, 532425, 532435, 532445 is the device name listed in this FDA 510(k) record. The listed applicant is Linvatec Biomaterials, Ltd.. It received FDA 510(k) clearance on 2003-07-25 under 510(k) number K031981. The device is classified under product code MAI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 2.4 SMARTNAIL, MODELS 532416, 532425, 532435, 532445?

2.4 SMARTNAIL, MODELS 532416, 532425, 532435, 532445 is a medical device that received FDA 510(k) clearance on 2003-07-25. The listed applicant is Linvatec Biomaterials, Ltd.. The 510(k) number is K031981.

When did 2.4 SMARTNAIL, MODELS 532416, 532425, 532435, 532445 receive FDA 510(k) clearance?

2.4 SMARTNAIL, MODELS 532416, 532425, 532435, 532445 received FDA 510(k) clearance on 2003-07-25, under 510(k) number K031981.

Who is the listed applicant for 2.4 SMARTNAIL, MODELS 532416, 532425, 532435, 532445?

The FDA 510(k) record lists Linvatec Biomaterials, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 2.4 SMARTNAIL, MODELS 532416, 532425, 532435, 532445?

The FDA product code for 2.4 SMARTNAIL, MODELS 532416, 532425, 532435, 532445 is MAI.

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Other records listing Linvatec Biomaterials, Ltd. as applicant

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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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