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FDA 510(k)

TITANIUM ALLOY SONGER CABLE SYSTEM

K-Number: K920201 · 1992-04-08

ApplicantSofamor Danek Mfg., Inc.
Decision Date1992-04-08
Product CodeJDQ
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

TITANIUM ALLOY SONGER CABLE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Sofamor Danek Mfg., Inc.. It received FDA 510(k) clearance on 1992-04-08 under 510(k) number K920201. The device is classified under product code JDQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the TITANIUM ALLOY SONGER CABLE SYSTEM?

TITANIUM ALLOY SONGER CABLE SYSTEM is a medical device that received FDA 510(k) clearance on 1992-04-08. The listed applicant is Sofamor Danek Mfg., Inc.. The 510(k) number is K920201.

When did TITANIUM ALLOY SONGER CABLE SYSTEM receive FDA 510(k) clearance?

TITANIUM ALLOY SONGER CABLE SYSTEM received FDA 510(k) clearance on 1992-04-08, under 510(k) number K920201.

Who is the listed applicant for TITANIUM ALLOY SONGER CABLE SYSTEM?

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

What is the FDA product code for TITANIUM ALLOY SONGER CABLE SYSTEM?

The FDA product code for TITANIUM ALLOY SONGER CABLE SYSTEM is JDQ.

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Other records listing Sofamor Danek Mfg., Inc. as applicant

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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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