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FDA 510(k)

3.7MM/5.0MM DYNAMIC LOCKING SCREW

K-Number: K110592 · 2011-07-25

ApplicantSynthes USA
Decision Date2011-07-25
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

3.7MM/5.0MM DYNAMIC LOCKING SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Synthes USA. It received FDA 510(k) clearance on 2011-07-25 under 510(k) number K110592. 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 3.7MM/5.0MM DYNAMIC LOCKING SCREW?

3.7MM/5.0MM DYNAMIC LOCKING SCREW is a medical device that received FDA 510(k) clearance on 2011-07-25. The listed applicant is Synthes USA. The 510(k) number is K110592.

When did 3.7MM/5.0MM DYNAMIC LOCKING SCREW receive FDA 510(k) clearance?

3.7MM/5.0MM DYNAMIC LOCKING SCREW received FDA 510(k) clearance on 2011-07-25, under 510(k) number K110592.

Who is the listed applicant for 3.7MM/5.0MM DYNAMIC LOCKING SCREW?

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 3.7MM/5.0MM DYNAMIC LOCKING SCREW?

The FDA product code for 3.7MM/5.0MM DYNAMIC LOCKING SCREW is HWC. This falls under the Cardiovascular category.

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Other records listing Synthes USA as applicant

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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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