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FDA 510(k)

BOSS Toe Fixation System

K-Number: K190261 · 2019-08-14

ApplicantArthrosurface, Inc.
Decision Date2019-08-14
Product CodeKWD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BOSS Toe Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Arthrosurface, Inc.. It received FDA 510(k) clearance on 2019-08-14 under 510(k) number K190261. 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 BOSS Toe Fixation System?

BOSS Toe Fixation System is a medical device that received FDA 510(k) clearance on 2019-08-14. The listed applicant is Arthrosurface, Inc.. The 510(k) number is K190261.

When did BOSS Toe Fixation System receive FDA 510(k) clearance?

BOSS Toe Fixation System received FDA 510(k) clearance on 2019-08-14, under 510(k) number K190261.

Who is the listed applicant for BOSS Toe Fixation System?

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

What is the FDA product code for BOSS Toe Fixation System?

The FDA product code for BOSS Toe Fixation System is KWD.

Other records listing Arthrosurface, Inc. 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.

K203375OVOMotion Reverse Shoulder Arthroplasty SystemK200718Arthrosurface WristMotion Total Wrist Arthroplasty SystemK181280Patello-Femoral Wave (Kahuna) Arthroplasty SystemK173964OVOMotion Shoulder Arthroplasty SystemK172383Arthrosurface Bone ScrewsK170440KISSloc Suture System

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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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