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FDA 510(k)

SYNTHES 3.0MM HEADLESS COMPRESSION SCREWS

K-Number: K050636 · 2005-04-21

ApplicantSynthes (Usa)
Decision Date2005-04-21
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SYNTHES 3.0MM HEADLESS COMPRESSION SCREWS is the device name listed in this FDA 510(k) record. The listed applicant is Synthes (Usa). It received FDA 510(k) clearance on 2005-04-21 under 510(k) number K050636. 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 SYNTHES 3.0MM HEADLESS COMPRESSION SCREWS?

SYNTHES 3.0MM HEADLESS COMPRESSION SCREWS is a medical device that received FDA 510(k) clearance on 2005-04-21. The listed applicant is Synthes (Usa). The 510(k) number is K050636.

When did SYNTHES 3.0MM HEADLESS COMPRESSION SCREWS receive FDA 510(k) clearance?

SYNTHES 3.0MM HEADLESS COMPRESSION SCREWS received FDA 510(k) clearance on 2005-04-21, under 510(k) number K050636.

Who is the listed applicant for SYNTHES 3.0MM HEADLESS COMPRESSION SCREWS?

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 SYNTHES 3.0MM HEADLESS COMPRESSION SCREWS?

The FDA product code for SYNTHES 3.0MM HEADLESS COMPRESSION SCREWS is HWC. This falls under the Cardiovascular category.

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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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