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FDA 510(k)

BIOCRYL RAPIDE INTERFERENCE SCREW

K-Number: K032717 · 2004-03-31

ApplicantMitek Worldwide
Decision Date2004-03-31
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BIOCRYL RAPIDE INTERFERENCE SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Mitek Worldwide. It received FDA 510(k) clearance on 2004-03-31 under 510(k) number K032717. 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 BIOCRYL RAPIDE INTERFERENCE SCREW?

BIOCRYL RAPIDE INTERFERENCE SCREW is a medical device that received FDA 510(k) clearance on 2004-03-31. The listed applicant is Mitek Worldwide. The 510(k) number is K032717.

When did BIOCRYL RAPIDE INTERFERENCE SCREW receive FDA 510(k) clearance?

BIOCRYL RAPIDE INTERFERENCE SCREW received FDA 510(k) clearance on 2004-03-31, under 510(k) number K032717.

Who is the listed applicant for BIOCRYL RAPIDE INTERFERENCE SCREW?

The FDA 510(k) record lists Mitek Worldwide as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIOCRYL RAPIDE INTERFERENCE SCREW?

The FDA product code for BIOCRYL RAPIDE INTERFERENCE SCREW is HWC. This falls under the Cardiovascular category.

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Other records listing Mitek Worldwide as applicant

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Related Devices (Code: HWC)

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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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