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FDA 510(k)

BONE-LOK BIOABSORBABLE COMPRESSION ANCHOR WITH TITANIUM FIXTURE , MODEL BMCD-35-3040, MBCD-35-4050

K-Number: K014243 · 2002-03-26

ApplicantTriage Medical, Inc.
Decision Date2002-03-26
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BONE-LOK BIOABSORBABLE COMPRESSION ANCHOR WITH TITANIUM FIXTURE , MODEL BMCD-35-3040, MBCD-35-4050 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 2002-03-26 under 510(k) number K014243. 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 BONE-LOK BIOABSORBABLE COMPRESSION ANCHOR WITH TITANIUM FIXTURE , MODEL BMCD-35-3040, MBCD-35-4050?

BONE-LOK BIOABSORBABLE COMPRESSION ANCHOR WITH TITANIUM FIXTURE , MODEL BMCD-35-3040, MBCD-35-4050 is a medical device that received FDA 510(k) clearance on 2002-03-26. The listed applicant is Triage Medical, Inc.. The 510(k) number is K014243.

When did BONE-LOK BIOABSORBABLE COMPRESSION ANCHOR WITH TITANIUM FIXTURE , MODEL BMCD-35-3040, MBCD-35-4050 receive FDA 510(k) clearance?

BONE-LOK BIOABSORBABLE COMPRESSION ANCHOR WITH TITANIUM FIXTURE , MODEL BMCD-35-3040, MBCD-35-4050 received FDA 510(k) clearance on 2002-03-26, under 510(k) number K014243.

Who is the listed applicant for BONE-LOK BIOABSORBABLE COMPRESSION ANCHOR WITH TITANIUM FIXTURE , MODEL BMCD-35-3040, MBCD-35-4050?

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 BIOABSORBABLE COMPRESSION ANCHOR WITH TITANIUM FIXTURE , MODEL BMCD-35-3040, MBCD-35-4050?

The FDA product code for BONE-LOK BIOABSORBABLE COMPRESSION ANCHOR WITH TITANIUM FIXTURE , MODEL BMCD-35-3040, MBCD-35-4050 is HWC. This falls under the Cardiovascular category.

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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.

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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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