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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 a medical device manufactured by Arthrosurface, Inc.. It received FDA 510(k) clearance on 2019-08-14 under approval 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. It is manufactured by Arthrosurface, Inc.. The 510(k) number is K190261.

When was BOSS Toe Fixation System approved by the FDA?

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

What company makes BOSS Toe Fixation System?

BOSS Toe Fixation System is manufactured by Arthrosurface, Inc..

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

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

Related Clinical Trials

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Other Devices by Arthrosurface, Inc.

K161539Arthrosurface Bone Screws K152454HemiCAP MTP Resurfacing Hemi-Arthroplasty System K172383Arthrosurface Bone Screws K170440KISSloc Suture System K170350ToeMATE® Hammertoe Correction System K162391AlignMATE™ Lapidus Arthrodesis System

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Related Devices (Code: KWD)

K152454HemiCAP MTP Resurfacing Hemi-Arthroplasty SystemArthrosurface, Inc. K161279Life Spine Metatarsal Hemi ImplantLife Spine, Inc. K190543Cannulated Hemi ImplantVilex IN Tennessee, Inc. K200951Accu-Joint Hemi ImplantAccufix Surgical, Inc. K203634BioPoly Great Toe Hemiarthroplasty ImplantBioPoly, LLC K222964BioPoly Lesser 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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