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FDA 510(k)

3S HEMI TOE

K-Number: K072922 · 2007-11-28

ApplicantTrilliant Surgical, Ltd.
Decision Date2007-11-28
Product CodeKWD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

3S HEMI TOE is the device name listed in this FDA 510(k) record. The listed applicant is Trilliant Surgical, Ltd.. It received FDA 510(k) clearance on 2007-11-28 under 510(k) number K072922. 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 3S HEMI TOE?

3S HEMI TOE is a medical device that received FDA 510(k) clearance on 2007-11-28. The listed applicant is Trilliant Surgical, Ltd.. The 510(k) number is K072922.

When did 3S HEMI TOE receive FDA 510(k) clearance?

3S HEMI TOE received FDA 510(k) clearance on 2007-11-28, under 510(k) number K072922.

Who is the listed applicant for 3S HEMI TOE?

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

What is the FDA product code for 3S HEMI TOE?

The FDA product code for 3S HEMI TOE is KWD.

Other records listing Trilliant Surgical, Ltd. as applicant

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Related Devices (Code: KWD)

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.

K250074HYALEX® MTP Hemiarthroplasty ImplantHyalex Orthopaedics, Inc.K240268Accu-Joint Hemi ImplantAccufix Surgical, Inc.K221220Montross Extremity Medical Hemi Implant SystemMontross Extremity MedicalK222964BioPoly Lesser Toe Hemiarthroplasty ImplantBioPoly, LLCK201393restor3d MTP ImplantRestor3D, Inc.K203634BioPoly Great Toe Hemiarthroplasty ImplantBioPoly, LLC

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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