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FDA 510(k)

LINK CERCLAGE WIRE SYSTEM

K-Number: K970084 · 1997-03-13

ApplicantTurnkey Intergration USA, Inc.
Decision Date1997-03-13
Product CodeJDQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LINK CERCLAGE WIRE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Turnkey Intergration USA, Inc.. It received FDA 510(k) clearance on 1997-03-13 under 510(k) number K970084. The device is classified under product code JDQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LINK CERCLAGE WIRE SYSTEM?

LINK CERCLAGE WIRE SYSTEM is a medical device that received FDA 510(k) clearance on 1997-03-13. The listed applicant is Turnkey Intergration USA, Inc.. The 510(k) number is K970084.

When did LINK CERCLAGE WIRE SYSTEM receive FDA 510(k) clearance?

LINK CERCLAGE WIRE SYSTEM received FDA 510(k) clearance on 1997-03-13, under 510(k) number K970084.

Who is the listed applicant for LINK CERCLAGE WIRE SYSTEM?

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

What is the FDA product code for LINK CERCLAGE WIRE SYSTEM?

The FDA product code for LINK CERCLAGE WIRE SYSTEM is JDQ.

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Other records listing Turnkey Intergration USA, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: JDQ)

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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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