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FDA 510(k)

VERTELINK KOBRA SPINAL FIXATION SYSTEM

K-Number: K032102 · 2003-12-12

ApplicantVertelink Corporation
Decision Date2003-12-12
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

VERTELINK KOBRA SPINAL FIXATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Vertelink Corporation. It received FDA 510(k) clearance on 2003-12-12 under 510(k) number K032102. 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 VERTELINK KOBRA SPINAL FIXATION SYSTEM?

VERTELINK KOBRA SPINAL FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 2003-12-12. The listed applicant is Vertelink Corporation. The 510(k) number is K032102.

When did VERTELINK KOBRA SPINAL FIXATION SYSTEM receive FDA 510(k) clearance?

VERTELINK KOBRA SPINAL FIXATION SYSTEM received FDA 510(k) clearance on 2003-12-12, under 510(k) number K032102.

Who is the listed applicant for VERTELINK KOBRA SPINAL FIXATION SYSTEM?

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

What is the FDA product code for VERTELINK KOBRA SPINAL FIXATION SYSTEM?

The FDA product code for VERTELINK KOBRA SPINAL FIXATION 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 Vertelink Corporation 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.

K030734PATHWAY ACCESS SHEATH CATHETERK030662PATHWAY ACCESS SHEATH CATHETER

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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