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FDA 510(k)

SYNTHES 3.5MM LOW PROFILE CORTICAL SCREW

K-Number: K111230 · 2011-05-24

ApplicantSynthes (USA) Products, LLC
Decision Date2011-05-24
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SYNTHES 3.5MM LOW PROFILE CORTICAL SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Synthes (USA) Products, LLC. It received FDA 510(k) clearance on 2011-05-24 under 510(k) number K111230. 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 3.5MM LOW PROFILE CORTICAL SCREW?

SYNTHES 3.5MM LOW PROFILE CORTICAL SCREW is a medical device that received FDA 510(k) clearance on 2011-05-24. The listed applicant is Synthes (USA) Products, LLC. The 510(k) number is K111230.

When did SYNTHES 3.5MM LOW PROFILE CORTICAL SCREW receive FDA 510(k) clearance?

SYNTHES 3.5MM LOW PROFILE CORTICAL SCREW received FDA 510(k) clearance on 2011-05-24, under 510(k) number K111230.

Who is the listed applicant for SYNTHES 3.5MM LOW PROFILE CORTICAL SCREW?

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

What is the FDA product code for SYNTHES 3.5MM LOW PROFILE CORTICAL SCREW?

The FDA product code for SYNTHES 3.5MM LOW PROFILE CORTICAL SCREW 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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