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)

3.8MM CS FACET COMPRESSION DEVICE

K-Number: K052043 · 2005-10-17

ApplicantTriage Medical, Inc.
Decision Date2005-10-17
Product CodeMRW
DecisionSubstantially Equivalent

Device Summary

3.8MM CS FACET COMPRESSION DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Triage Medical, Inc.. It received FDA 510(k) clearance on 2005-10-17 under 510(k) number K052043. The device is classified under product code MRW. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 3.8MM CS FACET COMPRESSION DEVICE?

3.8MM CS FACET COMPRESSION DEVICE is a medical device that received FDA 510(k) clearance on 2005-10-17. The listed applicant is Triage Medical, Inc.. The 510(k) number is K052043.

When did 3.8MM CS FACET COMPRESSION DEVICE receive FDA 510(k) clearance?

3.8MM CS FACET COMPRESSION DEVICE received FDA 510(k) clearance on 2005-10-17, under 510(k) number K052043.

Who is the listed applicant for 3.8MM CS FACET COMPRESSION DEVICE?

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

What is the FDA product code for 3.8MM CS FACET COMPRESSION DEVICE?

The FDA product code for 3.8MM CS FACET COMPRESSION DEVICE is MRW.

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 Triage Medical, 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.

K062391DISPOSABLE POSTERIOR LUMBAR STABILIZATION PROCEDURE KIT, MODELS 9045-01 AND 9045-02; COMPRESSION TOOL, MODEL 6113-00K0519494.5 MM LS FACET COMPRESSION DEVICE WITH POLYMER WASHER, MODEL LSPW-45-3040K0433514.5MM BONE-LOK FACET SCREW, MODELS TFCD-45-3040S OR N; SFCD-45-3040S OR NK042244BONE-LOK MVP CORTICAL-CANCELLOUS COMPRESSION DEVICEK040250BONE-LOK HP WASHERK014304BONE-LOK BIOABSORBABLE COMPRESSION ANCHOR, MODEL BMCD-35-3050S

View all 11 devices →

Related Devices (Code: MRW)

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.

K262618Arthrex Spine Compression FT ScrewArthrex, Inc.K261209Ion-LSurGenTec, LLCK253676CORUS™ Posterior Cervical Stabilization System 3D (CORUS™ PCSS 3D)Providence Medical Technology, Inc.K253432DiversiVy™ Facet Screw SystemVy Spine, LLCK251714Ion-CSurGenTec, LLCK250679FFX Facet Fixation SystemSc Medica

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.

↑