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FDA 510(k)

KOBY SURGICAL INTERNAL FIXATION SYSTEM

K-Number: K060026 · 2006-01-26

ApplicantKoby Surgical
Decision Date2006-01-26
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

KOBY SURGICAL INTERNAL FIXATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Koby Surgical. It received FDA 510(k) clearance on 2006-01-26 under 510(k) number K060026. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KOBY SURGICAL INTERNAL FIXATION SYSTEM?

KOBY SURGICAL INTERNAL FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 2006-01-26. The listed applicant is Koby Surgical. The 510(k) number is K060026.

When did KOBY SURGICAL INTERNAL FIXATION SYSTEM receive FDA 510(k) clearance?

KOBY SURGICAL INTERNAL FIXATION SYSTEM received FDA 510(k) clearance on 2006-01-26, under 510(k) number K060026.

Who is the listed applicant for KOBY SURGICAL INTERNAL FIXATION SYSTEM?

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

What is the FDA product code for KOBY SURGICAL INTERNAL FIXATION SYSTEM?

The FDA product code for KOBY SURGICAL INTERNAL FIXATION SYSTEM is HWC. This falls under the Cardiovascular category.

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Related Devices (Code: HWC)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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