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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 the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 2020-02-20 under 510(k) 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. The listed applicant is Biomet, Inc.. The 510(k) number is K193533.

When did WIN Flexible Nail System receive FDA 510(k) clearance?

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

Who is the listed applicant for WIN Flexible Nail System?

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

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

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

Other records listing Biomet, Inc. 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.

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Related Devices (Code: JDS)

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.

K243608TRIGEN Stable Lock Nut & WasherSmith & 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.K230761TRIGEN META-NAIL Nail SystemSmith & Nephew, Inc.K201336DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Screws Medullary Nails, 4.0 and 5.0mmSynthes (USA) Products, 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.

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