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FDA 510(k)

SBI FOOT AND ANKLE CANNULATED SCREW SYSTEM, MODEL 100-0061

K-Number: K092754 · 2010-01-19

ApplicantSmall Bone Innovations, Inc.
Decision Date2010-01-19
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SBI FOOT AND ANKLE CANNULATED SCREW SYSTEM, MODEL 100-0061 is the device name listed in this FDA 510(k) record. The listed applicant is Small Bone Innovations, Inc.. It received FDA 510(k) clearance on 2010-01-19 under 510(k) number K092754. 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 SBI FOOT AND ANKLE CANNULATED SCREW SYSTEM, MODEL 100-0061?

SBI FOOT AND ANKLE CANNULATED SCREW SYSTEM, MODEL 100-0061 is a medical device that received FDA 510(k) clearance on 2010-01-19. The listed applicant is Small Bone Innovations, Inc.. The 510(k) number is K092754.

When did SBI FOOT AND ANKLE CANNULATED SCREW SYSTEM, MODEL 100-0061 receive FDA 510(k) clearance?

SBI FOOT AND ANKLE CANNULATED SCREW SYSTEM, MODEL 100-0061 received FDA 510(k) clearance on 2010-01-19, under 510(k) number K092754.

Who is the listed applicant for SBI FOOT AND ANKLE CANNULATED SCREW SYSTEM, MODEL 100-0061?

The FDA 510(k) record lists Small Bone Innovations, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SBI FOOT AND ANKLE CANNULATED SCREW SYSTEM, MODEL 100-0061?

The FDA product code for SBI FOOT AND ANKLE CANNULATED SCREW SYSTEM, MODEL 100-0061 is HWC. This falls under the Cardiovascular category.

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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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