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 a medical device manufactured by BioPoly, LLC. It received FDA 510(k) clearance on 2022-11-22 under approval 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. It is manufactured by BioPoly, LLC. The 510(k) number is K222964.
When was BioPoly Lesser Toe Hemiarthroplasty Implant approved by the FDA?
BioPoly Lesser Toe Hemiarthroplasty Implant received FDA 510(k) clearance on 2022-11-22, under approval number K222964.
What company makes BioPoly Lesser Toe Hemiarthroplasty Implant?
BioPoly Lesser Toe Hemiarthroplasty Implant is manufactured by BioPoly, LLC.
What is the FDA product code for BioPoly Lesser Toe Hemiarthroplasty Implant?
The FDA product code for BioPoly Lesser Toe Hemiarthroplasty Implant is KWD.
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K190543Cannulated Hemi ImplantVilex IN Tennessee, Inc.
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K203634BioPoly Great 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.