Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

AXSOS 3 TI LOCKING PLATE SYSTEM LINE EXTENSION

K-Number: K133440 · 2013-12-18

ApplicantStryker Trauma AG
Decision Date2013-12-18
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AXSOS 3 TI LOCKING PLATE SYSTEM LINE EXTENSION 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 2013-12-18 under 510(k) number K133440. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AXSOS 3 TI LOCKING PLATE SYSTEM LINE EXTENSION?

AXSOS 3 TI LOCKING PLATE SYSTEM LINE EXTENSION is a medical device that received FDA 510(k) clearance on 2013-12-18. The listed applicant is Stryker Trauma AG. The 510(k) number is K133440.

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

AXSOS 3 TI LOCKING PLATE SYSTEM LINE EXTENSION received FDA 510(k) clearance on 2013-12-18, under 510(k) number K133440.

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

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 LINE EXTENSION?

The FDA product code for AXSOS 3 TI LOCKING PLATE SYSTEM LINE EXTENSION is HWC. This falls under the Cardiovascular category.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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)K132502VARIAX 2 SYSTEMK131365T2 TIBIAL NAILING SYSTEMK130907HOFFMANN LRF (LIMB RECONSTRUCTION FRAME) SYSTEMK131132PELVIS II IMPLANT SYSTEMK130334HOFFMANN LRF (LIMB RECONSTRUCTION FRAME SYSTEM)

View all 12 devices →

Related Devices (Code: HWC)

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.

K262975Arthrex Beaming SystemArthrex, Inc.K260995DynaNail Helix® Fixation SystemMedShape, Inc.K254280F.A.S.T ScrewSteps OrthoK261057ActivaScrew™ Cannulated COMBioretec, Ltd.K260106OsteoCoil™ GT Active Compression SystemFlower Orthopedics Corporation DBA Conventus Flower OrthopedK262344Large Compression ScrewsTriMed, Inc.

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.

↑