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FDA 510(k)

BioPoly Great Toe Hemiarthroplasty Implant

K-Number: K203634 · 2021-02-02

ApplicantBioPoly, LLC
Decision Date2021-02-02
Product CodeKWD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BioPoly Great Toe Hemiarthroplasty Implant is a medical device manufactured by BioPoly, LLC. It received FDA 510(k) clearance on 2021-02-02 under approval number K203634. 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 BioPoly Great Toe Hemiarthroplasty Implant?

BioPoly Great Toe Hemiarthroplasty Implant is a medical device that received FDA 510(k) clearance on 2021-02-02. It is manufactured by BioPoly, LLC. The 510(k) number is K203634.

When was BioPoly Great Toe Hemiarthroplasty Implant approved by the FDA?

BioPoly Great Toe Hemiarthroplasty Implant received FDA 510(k) clearance on 2021-02-02, under approval number K203634.

What company makes BioPoly Great Toe Hemiarthroplasty Implant?

BioPoly Great Toe Hemiarthroplasty Implant is manufactured by BioPoly, LLC.

What is the FDA product code for BioPoly Great Toe Hemiarthroplasty Implant?

The FDA product code for BioPoly Great Toe Hemiarthroplasty Implant is KWD.

Related Clinical Trials

NCT07538141 The Hyalex MTP Study RECRUITING

Related PubMed Literature

PMID: 39726899 How to improve the mechanical safety of a novel spinal implant while saving costs and time. JOR spine (2024)

Other Devices by BioPoly, LLC

K222964BioPoly Lesser Toe Hemiarthroplasty Implant K233592BioPoly Radial Head Implant

Related Devices (Code: KWD)

K152454HemiCAP MTP Resurfacing Hemi-Arthroplasty SystemArthrosurface, Inc. K161279Life Spine Metatarsal Hemi ImplantLife Spine, Inc. K190261BOSS Toe Fixation SystemArthrosurface, Inc. K190543Cannulated Hemi ImplantVilex IN Tennessee, Inc. K200951Accu-Joint Hemi ImplantAccufix Surgical, Inc. 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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