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FDA 510(k)

4.5MM BONE-LOK FACET SCREW, MODELS TFCD-45-3040S OR N; SFCD-45-3040S OR N

K-Number: K043351 · 2005-02-18

ApplicantTriage Medical, Inc.
Decision Date2005-02-18
Product CodeMRW
DecisionSubstantially Equivalent

Device Summary

4.5MM BONE-LOK FACET SCREW, MODELS TFCD-45-3040S OR N; SFCD-45-3040S OR N 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 2005-02-18 under 510(k) number K043351. The device is classified under product code MRW. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 4.5MM BONE-LOK FACET SCREW, MODELS TFCD-45-3040S OR N; SFCD-45-3040S OR N?

4.5MM BONE-LOK FACET SCREW, MODELS TFCD-45-3040S OR N; SFCD-45-3040S OR N is a medical device that received FDA 510(k) clearance on 2005-02-18. The listed applicant is Triage Medical, Inc.. The 510(k) number is K043351.

When did 4.5MM BONE-LOK FACET SCREW, MODELS TFCD-45-3040S OR N; SFCD-45-3040S OR N receive FDA 510(k) clearance?

4.5MM BONE-LOK FACET SCREW, MODELS TFCD-45-3040S OR N; SFCD-45-3040S OR N received FDA 510(k) clearance on 2005-02-18, under 510(k) number K043351.

Who is the listed applicant for 4.5MM BONE-LOK FACET SCREW, MODELS TFCD-45-3040S OR N; SFCD-45-3040S OR N?

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 4.5MM BONE-LOK FACET SCREW, MODELS TFCD-45-3040S OR N; SFCD-45-3040S OR N?

The FDA product code for 4.5MM BONE-LOK FACET SCREW, MODELS TFCD-45-3040S OR N; SFCD-45-3040S OR N is MRW.

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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 6113-00K0520433.8MM CS FACET COMPRESSION DEVICEK0519494.5 MM LS FACET COMPRESSION DEVICE WITH POLYMER WASHER, MODEL LSPW-45-3040K042244BONE-LOK MVP CORTICAL-CANCELLOUS COMPRESSION DEVICEK040250BONE-LOK HP WASHERK014304BONE-LOK BIOABSORBABLE COMPRESSION ANCHOR, MODEL BMCD-35-3050S

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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.

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