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FDA 510(k)

2.4MM CORTEX SCREW, SELF-TAPPING

K-Number: K002271 · 2000-08-25

ApplicantSynthes (Usa)
Decision Date2000-08-25
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

2.4MM CORTEX SCREW, SELF-TAPPING is the device name listed in this FDA 510(k) record. The listed applicant is Synthes (Usa). It received FDA 510(k) clearance on 2000-08-25 under 510(k) number K002271. 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 2.4MM CORTEX SCREW, SELF-TAPPING?

2.4MM CORTEX SCREW, SELF-TAPPING is a medical device that received FDA 510(k) clearance on 2000-08-25. The listed applicant is Synthes (Usa). The 510(k) number is K002271.

When did 2.4MM CORTEX SCREW, SELF-TAPPING receive FDA 510(k) clearance?

2.4MM CORTEX SCREW, SELF-TAPPING received FDA 510(k) clearance on 2000-08-25, under 510(k) number K002271.

Who is the listed applicant for 2.4MM CORTEX SCREW, SELF-TAPPING?

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

What is the FDA product code for 2.4MM CORTEX SCREW, SELF-TAPPING?

The FDA product code for 2.4MM CORTEX SCREW, SELF-TAPPING is HWC. This falls under the Cardiovascular category.

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Related Devices (Code: HWC)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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