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FDA 510(k)

EXOSHAPE DUO SOFT TISSUE FASTENER

K-Number: K132783 · 2013-12-09

ApplicantMedShape, Inc.
Decision Date2013-12-09
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EXOSHAPE DUO SOFT TISSUE FASTENER is the device name listed in this FDA 510(k) record. The listed applicant is MedShape, Inc.. It received FDA 510(k) clearance on 2013-12-09 under 510(k) number K132783. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXOSHAPE DUO SOFT TISSUE FASTENER?

EXOSHAPE DUO SOFT TISSUE FASTENER is a medical device that received FDA 510(k) clearance on 2013-12-09. The listed applicant is MedShape, Inc.. The 510(k) number is K132783.

When did EXOSHAPE DUO SOFT TISSUE FASTENER receive FDA 510(k) clearance?

EXOSHAPE DUO SOFT TISSUE FASTENER received FDA 510(k) clearance on 2013-12-09, under 510(k) number K132783.

Who is the listed applicant for EXOSHAPE DUO SOFT TISSUE FASTENER?

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

What is the FDA product code for EXOSHAPE DUO SOFT TISSUE FASTENER?

The FDA product code for EXOSHAPE DUO SOFT TISSUE FASTENER is MBI.

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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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