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FDA 510(k)

BONE-LOK HP WASHER

K-Number: K040250 · 2004-03-23

ApplicantTriage Medical, Inc.
Decision Date2004-03-23
Product CodeHTN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BONE-LOK HP WASHER 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 2004-03-23 under 510(k) number K040250. The device is classified under product code HTN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BONE-LOK HP WASHER?

BONE-LOK HP WASHER is a medical device that received FDA 510(k) clearance on 2004-03-23. The listed applicant is Triage Medical, Inc.. The 510(k) number is K040250.

When did BONE-LOK HP WASHER receive FDA 510(k) clearance?

BONE-LOK HP WASHER received FDA 510(k) clearance on 2004-03-23, under 510(k) number K040250.

Who is the listed applicant for BONE-LOK HP WASHER?

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 BONE-LOK HP WASHER?

The FDA product code for BONE-LOK HP WASHER is HTN.

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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 DEVICEK014304BONE-LOK BIOABSORBABLE COMPRESSION ANCHOR, MODEL BMCD-35-3050S

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Related Devices (Code: HTN)

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.

K253115LARS ACJMovmedix S.A.S.K252081SportLinc Syndesmosis DeviceLincotek MedicalK253727Syndesmosis TightRope PROArthrex, Inc.K251643Synchfix EVTWright Medical Technology, Inc. (Stryker Corporation)K251134RipCordTriMed, Inc.K243624Acu-Sinch Knotless MiniAcumed, LLC

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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