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FDA 510(k)

AOS CANNULATED BONE SCREW SYSTEM

K-Number: K014185 · 2002-02-13

ApplicantAdvanced Orthopaedic Solutions, Inc.
Decision Date2002-02-13
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AOS CANNULATED BONE SCREW SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Orthopaedic Solutions, Inc.. It received FDA 510(k) clearance on 2002-02-13 under 510(k) number K014185. 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 AOS CANNULATED BONE SCREW SYSTEM?

AOS CANNULATED BONE SCREW SYSTEM is a medical device that received FDA 510(k) clearance on 2002-02-13. The listed applicant is Advanced Orthopaedic Solutions, Inc.. The 510(k) number is K014185.

When did AOS CANNULATED BONE SCREW SYSTEM receive FDA 510(k) clearance?

AOS CANNULATED BONE SCREW SYSTEM received FDA 510(k) clearance on 2002-02-13, under 510(k) number K014185.

Who is the listed applicant for AOS CANNULATED BONE SCREW SYSTEM?

The FDA 510(k) record lists Advanced Orthopaedic Solutions, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AOS CANNULATED BONE SCREW SYSTEM?

The FDA product code for AOS CANNULATED BONE SCREW SYSTEM is HWC. This falls under the Cardiovascular category.

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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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