FDA 510(k)

BioPoly Radial Head Implant

K-Number: K233592 · 2024-03-13

Decision Date2024-03-13

Product CodeKWI

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

BioPoly Radial Head Implant is a medical device manufactured by BioPoly, LLC. It received FDA 510(k) clearance on 2024-03-13 under approval 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. It is manufactured by BioPoly, LLC. The 510(k) number is K233592.

When was BioPoly Radial Head Implant approved by the FDA?

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

What company makes BioPoly Radial Head Implant?

BioPoly Radial Head Implant is manufactured by BioPoly, LLC.

What is the FDA product code for BioPoly Radial Head Implant?

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

Other Devices by BioPoly, LLC

K203634BioPoly Great Toe Hemiarthroplasty Implant K222964BioPoly Lesser Toe Hemiarthroplasty Implant

Related Devices (Code: KWI)

K172688Align Radial Head SystemSkeletal Dynamics, LLC K183618Revolution Radial HeadIgnite Orthopedics, Inc. K192754Avenger Radial Head SystemIn2bones USA, LLC K212872Avenger Radial Head SystemIn2bones USA, LLC K213563DePuy Synthes Radial Head Replacement SystemDePuy Synthes K231188ALIGN Radial Head SystemSkeletal Dynamics, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.