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FDA 510(k)

ENDOFORM RECONSTRUCTIVE TEMPLATE

K-Number: K130547 · 2013-05-31

ApplicantMesynthe, Ltd.
Decision Date2013-05-31
Product CodeFTM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ENDOFORM RECONSTRUCTIVE TEMPLATE is the device name listed in this FDA 510(k) record. The listed applicant is Mesynthe, Ltd.. It received FDA 510(k) clearance on 2013-05-31 under 510(k) number K130547. The device is classified under product code FTM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDOFORM RECONSTRUCTIVE TEMPLATE?

ENDOFORM RECONSTRUCTIVE TEMPLATE is a medical device that received FDA 510(k) clearance on 2013-05-31. The listed applicant is Mesynthe, Ltd.. The 510(k) number is K130547.

When did ENDOFORM RECONSTRUCTIVE TEMPLATE receive FDA 510(k) clearance?

ENDOFORM RECONSTRUCTIVE TEMPLATE received FDA 510(k) clearance on 2013-05-31, under 510(k) number K130547.

Who is the listed applicant for ENDOFORM RECONSTRUCTIVE TEMPLATE?

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

What is the FDA product code for ENDOFORM RECONSTRUCTIVE TEMPLATE?

The FDA product code for ENDOFORM RECONSTRUCTIVE TEMPLATE is FTM.

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Related Devices (Code: FTM)

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.

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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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