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FDA 510(k)

BioPoly Lesser Toe Hemiarthroplasty Implant

K-Number: K222964 · 2022-11-22

ApplicantBioPoly, LLC
Decision Date2022-11-22
Product CodeKWD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BioPoly Lesser Toe Hemiarthroplasty Implant is the device name listed in this FDA 510(k) record. The listed applicant is BioPoly, LLC. It received FDA 510(k) clearance on 2022-11-22 under 510(k) number K222964. 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 Lesser Toe Hemiarthroplasty Implant?

BioPoly Lesser Toe Hemiarthroplasty Implant is a medical device that received FDA 510(k) clearance on 2022-11-22. The listed applicant is BioPoly, LLC. The 510(k) number is K222964.

When did BioPoly Lesser Toe Hemiarthroplasty Implant receive FDA 510(k) clearance?

BioPoly Lesser Toe Hemiarthroplasty Implant received FDA 510(k) clearance on 2022-11-22, under 510(k) number K222964.

Who is the listed applicant for BioPoly Lesser Toe Hemiarthroplasty Implant?

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

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

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

Related Clinical Trials

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.

NCT06915363BioPoly® Partial Resurfacing Knee Implant IDERECRUITINGNCT07538141The Hyalex MTP StudyRECRUITING

Other records listing BioPoly, LLC 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.

K233592BioPoly Radial Head ImplantK203634BioPoly Great Toe Hemiarthroplasty Implant

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 MedicalK201393restor3d MTP ImplantRestor3D, Inc.K203634BioPoly Great Toe Hemiarthroplasty ImplantBioPoly, LLCK200951Accu-Joint Hemi ImplantAccufix Surgical, Inc.

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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