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FDA 510(k)

HBS HEADLESS BONE SCREW

K-Number: K030302 · 2003-08-08

ApplicantSchoening & Assoc., Inc.
Decision Date2003-08-08
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HBS HEADLESS BONE SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Schoening & Assoc., Inc.. It received FDA 510(k) clearance on 2003-08-08 under 510(k) number K030302. 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 HBS HEADLESS BONE SCREW?

HBS HEADLESS BONE SCREW is a medical device that received FDA 510(k) clearance on 2003-08-08. The listed applicant is Schoening & Assoc., Inc.. The 510(k) number is K030302.

When did HBS HEADLESS BONE SCREW receive FDA 510(k) clearance?

HBS HEADLESS BONE SCREW received FDA 510(k) clearance on 2003-08-08, under 510(k) number K030302.

Who is the listed applicant for HBS HEADLESS BONE SCREW?

The FDA 510(k) record lists Schoening & Assoc., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HBS HEADLESS BONE SCREW?

The FDA product code for HBS HEADLESS BONE SCREW 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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