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FDA 510(k)

DUAL ROD ANTERIOR FIXATOR SYSTEM

K-Number: K963780 · 1997-07-30

ApplicantSofamor Danek USA,Inc.
Decision Date1997-07-30
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DUAL ROD ANTERIOR FIXATOR SYSTEM 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 1997-07-30 under 510(k) number K963780. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DUAL ROD ANTERIOR FIXATOR SYSTEM?

DUAL ROD ANTERIOR FIXATOR SYSTEM is a medical device that received FDA 510(k) clearance on 1997-07-30. The listed applicant is Sofamor Danek USA,Inc.. The 510(k) number is K963780.

When did DUAL ROD ANTERIOR FIXATOR SYSTEM receive FDA 510(k) clearance?

DUAL ROD ANTERIOR FIXATOR SYSTEM received FDA 510(k) clearance on 1997-07-30, under 510(k) number K963780.

Who is the listed applicant for DUAL ROD ANTERIOR FIXATOR SYSTEM?

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 DUAL ROD ANTERIOR FIXATOR SYSTEM?

The FDA product code for DUAL ROD ANTERIOR FIXATOR SYSTEM is KWQ.

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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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