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FDA 510(k)

VARIAX 2 SYSTEM

K-Number: K132502 · 2013-10-23

ApplicantStryker Trauma AG
Decision Date2013-10-23
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

VARIAX 2 SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Trauma AG. It received FDA 510(k) clearance on 2013-10-23 under 510(k) number K132502. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VARIAX 2 SYSTEM?

VARIAX 2 SYSTEM is a medical device that received FDA 510(k) clearance on 2013-10-23. The listed applicant is Stryker Trauma AG. The 510(k) number is K132502.

When did VARIAX 2 SYSTEM receive FDA 510(k) clearance?

VARIAX 2 SYSTEM received FDA 510(k) clearance on 2013-10-23, under 510(k) number K132502.

Who is the listed applicant for VARIAX 2 SYSTEM?

The FDA 510(k) record lists Stryker Trauma AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VARIAX 2 SYSTEM?

The FDA product code for VARIAX 2 SYSTEM is HRS.

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Other records listing Stryker Trauma AG 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: HRS)

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.

K261892ProRib Fixation SystemCosta Surgical, Inc.K262098EnHAnce PEEK Bunion SystemNvision Biomedical TechnologiesK262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.K261647Tempo Plating System; Ultra Compression Screw SystemPace SurgicalK261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See Catalog);FRAXION Mini Plate System (Various - See Catalog);FRAXION Bone Screw System (Various - See Catalog)Ortler Global Tibbi Gerecler Anonim SirketiK262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.

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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