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FDA 510(k)

BioPoly Radial Head Implant

K-Number: K233592 · 2024-03-13

ApplicantBioPoly, LLC
Decision Date2024-03-13
Product CodeKWI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BioPoly Radial Head 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 2024-03-13 under 510(k) number K233592. The device is classified under product code KWI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BioPoly Radial Head Implant?

BioPoly Radial Head Implant is a medical device that received FDA 510(k) clearance on 2024-03-13. The listed applicant is BioPoly, LLC. The 510(k) number is K233592.

When did BioPoly Radial Head Implant receive FDA 510(k) clearance?

BioPoly Radial Head Implant received FDA 510(k) clearance on 2024-03-13, under 510(k) number K233592.

Who is the listed applicant for BioPoly Radial Head 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 Radial Head Implant?

The FDA product code for BioPoly Radial Head Implant is KWI.

Related Clinical Trials

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NCT06915363BioPoly® Partial Resurfacing Knee Implant IDERECRUITING

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.

K222964BioPoly Lesser Toe Hemiarthroplasty ImplantK203634BioPoly Great Toe Hemiarthroplasty Implant

Related Devices (Code: KWI)

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.

K260624Arthrex Radial Head Replacement SystemArthrex, Inc.K231188ALIGN Radial Head SystemSkeletal Dynamics, Inc.K213563DePuy Synthes Radial Head Replacement SystemDePuy SynthesK212872Avenger Radial Head SystemIn2bones USA, LLCK192754Avenger Radial Head SystemIn2bones USA, LLCK183618Revolution Radial HeadIgnite Orthopedics, 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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