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FDA 510(k)

WIN Flexible Nail System

K-Number: K193533 · 2020-02-20

ApplicantBiomet, Inc.
Decision Date2020-02-20
Product CodeJDS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

WIN Flexible Nail System is a medical device manufactured by Biomet, Inc.. It received FDA 510(k) clearance on 2020-02-20 under approval number K193533. The device is classified under product code JDS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WIN Flexible Nail System?

WIN Flexible Nail System is a medical device that received FDA 510(k) clearance on 2020-02-20. It is manufactured by Biomet, Inc.. The 510(k) number is K193533.

When was WIN Flexible Nail System approved by the FDA?

WIN Flexible Nail System received FDA 510(k) clearance on 2020-02-20, under approval number K193533.

What company makes WIN Flexible Nail System?

WIN Flexible Nail System is manufactured by Biomet, Inc..

What is the FDA product code for WIN Flexible Nail System?

The FDA product code for WIN Flexible Nail System is JDS.

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Related Devices (Code: JDS)

K201336DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Screws Medullary Nails, 4.0 and 5.0mmSynthes (USA) Products, LLC K192003Auxein Nailing SystemAuxein Medical Private Limited K230761TRIGEN META-NAIL Nail SystemSmith & Nephew, Inc. K240061TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail SystemSmith & Nephew, Inc. K241804TRIGEN INTERTAN 10S Nail SystemSmith & Nephew, Inc. K233150NET BRAND Osteosynthesis Nailing SystemNarang Medical , Ltd.

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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