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FDA 510(k)

TITANIUM COMPRESSION ANCHOR SYSTEM MODEL VERSION 2

K-Number: K012280 · 2001-08-17

ApplicantTriage Medical, Inc.
Decision Date2001-08-17
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TITANIUM COMPRESSION ANCHOR SYSTEM MODEL VERSION 2 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 2001-08-17 under 510(k) number K012280. 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 TITANIUM COMPRESSION ANCHOR SYSTEM MODEL VERSION 2?

TITANIUM COMPRESSION ANCHOR SYSTEM MODEL VERSION 2 is a medical device that received FDA 510(k) clearance on 2001-08-17. The listed applicant is Triage Medical, Inc.. The 510(k) number is K012280.

When did TITANIUM COMPRESSION ANCHOR SYSTEM MODEL VERSION 2 receive FDA 510(k) clearance?

TITANIUM COMPRESSION ANCHOR SYSTEM MODEL VERSION 2 received FDA 510(k) clearance on 2001-08-17, under 510(k) number K012280.

Who is the listed applicant for TITANIUM COMPRESSION ANCHOR SYSTEM MODEL VERSION 2?

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 TITANIUM COMPRESSION ANCHOR SYSTEM MODEL VERSION 2?

The FDA product code for TITANIUM COMPRESSION ANCHOR SYSTEM MODEL VERSION 2 is HWC. This falls under the Cardiovascular category.

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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-45-3040K0433514.5MM BONE-LOK FACET SCREW, MODELS TFCD-45-3040S OR N; SFCD-45-3040S OR NK042244BONE-LOK MVP CORTICAL-CANCELLOUS COMPRESSION DEVICEK040250BONE-LOK HP WASHER

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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.

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