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FDA 510(k)

SBI TRIHEDRON MTP HEMI GT

K-Number: K062040 · 2006-10-03

ApplicantSmall Bone Innovations, Inc.
Decision Date2006-10-03
Product CodeKWD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SBI TRIHEDRON MTP HEMI GT 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 2006-10-03 under 510(k) number K062040. The device is classified under product code KWD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SBI TRIHEDRON MTP HEMI GT?

SBI TRIHEDRON MTP HEMI GT is a medical device that received FDA 510(k) clearance on 2006-10-03. The listed applicant is Small Bone Innovations, Inc.. The 510(k) number is K062040.

When did SBI TRIHEDRON MTP HEMI GT receive FDA 510(k) clearance?

SBI TRIHEDRON MTP HEMI GT received FDA 510(k) clearance on 2006-10-03, under 510(k) number K062040.

Who is the listed applicant for SBI TRIHEDRON MTP HEMI GT?

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 TRIHEDRON MTP HEMI GT?

The FDA product code for SBI TRIHEDRON MTP HEMI GT is KWD.

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Related Devices (Code: KWD)

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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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