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FDA 510(k)

HIGHGATE CURVED ROD SYSTEM

K-Number: K012045 · 2002-03-12

ApplicantHighgate Orthopaedics
Decision Date2002-03-12
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HIGHGATE CURVED ROD SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Highgate Orthopaedics. It received FDA 510(k) clearance on 2002-03-12 under 510(k) number K012045. 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 HIGHGATE CURVED ROD SYSTEM?

HIGHGATE CURVED ROD SYSTEM is a medical device that received FDA 510(k) clearance on 2002-03-12. The listed applicant is Highgate Orthopaedics. The 510(k) number is K012045.

When did HIGHGATE CURVED ROD SYSTEM receive FDA 510(k) clearance?

HIGHGATE CURVED ROD SYSTEM received FDA 510(k) clearance on 2002-03-12, under 510(k) number K012045.

Who is the listed applicant for HIGHGATE CURVED ROD SYSTEM?

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

What is the FDA product code for HIGHGATE CURVED ROD SYSTEM?

The FDA product code for HIGHGATE CURVED ROD SYSTEM is KWQ.

Related Clinical Trials

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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Other records listing Highgate Orthopaedics 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.

K023983MODIFICATION TO HIGHGATE CURVED ROD SYSTEM

Related Devices (Code: KWQ)

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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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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