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FDA 510(k)

SURGICRAFT SCREW FIXATION SYSTEM

K-Number: K080447 · 2008-06-13

ApplicantSurgicraft , Ltd.
Decision Date2008-06-13
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SURGICRAFT SCREW FIXATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Surgicraft , Ltd.. It received FDA 510(k) clearance on 2008-06-13 under 510(k) number K080447. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGICRAFT SCREW FIXATION SYSTEM?

SURGICRAFT SCREW FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 2008-06-13. The listed applicant is Surgicraft , Ltd.. The 510(k) number is K080447.

When did SURGICRAFT SCREW FIXATION SYSTEM receive FDA 510(k) clearance?

SURGICRAFT SCREW FIXATION SYSTEM received FDA 510(k) clearance on 2008-06-13, under 510(k) number K080447.

Who is the listed applicant for SURGICRAFT SCREW FIXATION SYSTEM?

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

What is the FDA product code for SURGICRAFT SCREW FIXATION SYSTEM?

The FDA product code for SURGICRAFT SCREW FIXATION SYSTEM is MBI.

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Other records listing Surgicraft , Ltd. 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: MBI)

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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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