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FDA 510(k)

SBI TWISTOFIX

K-Number: K071541 · 2007-09-10

ApplicantSmall Bone Innovations, Inc.
Decision Date2007-09-10
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SBI TWISTOFIX 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 2007-09-10 under 510(k) number K071541. 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 TWISTOFIX?

SBI TWISTOFIX is a medical device that received FDA 510(k) clearance on 2007-09-10. The listed applicant is Small Bone Innovations, Inc.. The 510(k) number is K071541.

When did SBI TWISTOFIX receive FDA 510(k) clearance?

SBI TWISTOFIX received FDA 510(k) clearance on 2007-09-10, under 510(k) number K071541.

Who is the listed applicant for SBI TWISTOFIX?

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 TWISTOFIX?

The FDA product code for SBI TWISTOFIX 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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