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FDA 510(k)

AXSOS 3 TI LOCKING PLATE SYSTEM

K-Number: K123964 · 2013-03-28

ApplicantStryker Trauma AG
Decision Date2013-03-28
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AXSOS 3 TI LOCKING PLATE 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 2013-03-28 under 510(k) number K123964. 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 AXSOS 3 TI LOCKING PLATE SYSTEM?

AXSOS 3 TI LOCKING PLATE SYSTEM is a medical device that received FDA 510(k) clearance on 2013-03-28. The listed applicant is Stryker Trauma AG. The 510(k) number is K123964.

When did AXSOS 3 TI LOCKING PLATE SYSTEM receive FDA 510(k) clearance?

AXSOS 3 TI LOCKING PLATE SYSTEM received FDA 510(k) clearance on 2013-03-28, under 510(k) number K123964.

Who is the listed applicant for AXSOS 3 TI LOCKING PLATE 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 AXSOS 3 TI LOCKING PLATE SYSTEM?

The FDA product code for AXSOS 3 TI LOCKING PLATE 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.

K172210ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA)K133440AXSOS 3 TI LOCKING PLATE SYSTEM LINE EXTENSIONK132502VARIAX 2 SYSTEMK131365T2 TIBIAL NAILING SYSTEMK130907HOFFMANN LRF (LIMB RECONSTRUCTION FRAME) SYSTEMK131132PELVIS II IMPLANT SYSTEM

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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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