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FDA 510(k)

EXOSHAPE (TM) INTERFERENCE FIXATION DEVICE MODEL 1100-00-XXXX (VARIES BY SIZE)

K-Number: K111471 · 2011-06-10

ApplicantMedshape Solutions, Inc.
Decision Date2011-06-10
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EXOSHAPE (TM) INTERFERENCE FIXATION DEVICE MODEL 1100-00-XXXX (VARIES BY SIZE) is the device name listed in this FDA 510(k) record. The listed applicant is Medshape Solutions, Inc.. It received FDA 510(k) clearance on 2011-06-10 under 510(k) number K111471. 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 (TM) INTERFERENCE FIXATION DEVICE MODEL 1100-00-XXXX (VARIES BY SIZE)?

EXOSHAPE (TM) INTERFERENCE FIXATION DEVICE MODEL 1100-00-XXXX (VARIES BY SIZE) is a medical device that received FDA 510(k) clearance on 2011-06-10. The listed applicant is Medshape Solutions, Inc.. The 510(k) number is K111471.

When did EXOSHAPE (TM) INTERFERENCE FIXATION DEVICE MODEL 1100-00-XXXX (VARIES BY SIZE) receive FDA 510(k) clearance?

EXOSHAPE (TM) INTERFERENCE FIXATION DEVICE MODEL 1100-00-XXXX (VARIES BY SIZE) received FDA 510(k) clearance on 2011-06-10, under 510(k) number K111471.

Who is the listed applicant for EXOSHAPE (TM) INTERFERENCE FIXATION DEVICE MODEL 1100-00-XXXX (VARIES BY SIZE)?

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

What is the FDA product code for EXOSHAPE (TM) INTERFERENCE FIXATION DEVICE MODEL 1100-00-XXXX (VARIES BY SIZE)?

The FDA product code for EXOSHAPE (TM) INTERFERENCE FIXATION DEVICE MODEL 1100-00-XXXX (VARIES BY SIZE) 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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