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FDA 510(k)

PROPHECY PRE-OPERATIVE NAVIGATION ALIGNMENT GUIDES

K-Number: K103598 · 2011-10-17

ApplicantWrightmedicaltechnologyinc
Decision Date2011-10-17
Product CodeMBH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PROPHECY PRE-OPERATIVE NAVIGATION ALIGNMENT GUIDES is the device name listed in this FDA 510(k) record. The listed applicant is Wrightmedicaltechnologyinc. It received FDA 510(k) clearance on 2011-10-17 under 510(k) number K103598. The device is classified under product code MBH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROPHECY PRE-OPERATIVE NAVIGATION ALIGNMENT GUIDES?

PROPHECY PRE-OPERATIVE NAVIGATION ALIGNMENT GUIDES is a medical device that received FDA 510(k) clearance on 2011-10-17. The listed applicant is Wrightmedicaltechnologyinc. The 510(k) number is K103598.

When did PROPHECY PRE-OPERATIVE NAVIGATION ALIGNMENT GUIDES receive FDA 510(k) clearance?

PROPHECY PRE-OPERATIVE NAVIGATION ALIGNMENT GUIDES received FDA 510(k) clearance on 2011-10-17, under 510(k) number K103598.

Who is the listed applicant for PROPHECY PRE-OPERATIVE NAVIGATION ALIGNMENT GUIDES?

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

What is the FDA product code for PROPHECY PRE-OPERATIVE NAVIGATION ALIGNMENT GUIDES?

The FDA product code for PROPHECY PRE-OPERATIVE NAVIGATION ALIGNMENT GUIDES is MBH.

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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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