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FDA 510(k)

MICRO-ENDO(TM) INSTRUMENTS

K-Number: K950130 · 1995-05-01

ApplicantSofamor Danek USA,Inc.
Decision Date1995-05-01
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MICRO-ENDO(TM) INSTRUMENTS is the device name listed in this FDA 510(k) record. The listed applicant is Sofamor Danek USA,Inc.. It received FDA 510(k) clearance on 1995-05-01 under 510(k) number K950130. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICRO-ENDO(TM) INSTRUMENTS?

MICRO-ENDO(TM) INSTRUMENTS is a medical device that received FDA 510(k) clearance on 1995-05-01. The listed applicant is Sofamor Danek USA,Inc.. The 510(k) number is K950130.

When did MICRO-ENDO(TM) INSTRUMENTS receive FDA 510(k) clearance?

MICRO-ENDO(TM) INSTRUMENTS received FDA 510(k) clearance on 1995-05-01, under 510(k) number K950130.

Who is the listed applicant for MICRO-ENDO(TM) INSTRUMENTS?

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

What is the FDA product code for MICRO-ENDO(TM) INSTRUMENTS?

The FDA product code for MICRO-ENDO(TM) INSTRUMENTS is HRX.

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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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