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FDA 510(k)

HEADLESS COMPRESSION SCREW

K-Number: K112672 · 2011-12-13

ApplicantSkeletal Dynamics, LLC
Decision Date2011-12-13
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HEADLESS COMPRESSION SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Skeletal Dynamics, LLC. It received FDA 510(k) clearance on 2011-12-13 under 510(k) number K112672. 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 HEADLESS COMPRESSION SCREW?

HEADLESS COMPRESSION SCREW is a medical device that received FDA 510(k) clearance on 2011-12-13. The listed applicant is Skeletal Dynamics, LLC. The 510(k) number is K112672.

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

HEADLESS COMPRESSION SCREW received FDA 510(k) clearance on 2011-12-13, under 510(k) number K112672.

Who is the listed applicant for HEADLESS COMPRESSION SCREW?

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

What is the FDA product code for HEADLESS COMPRESSION SCREW?

The FDA product code for HEADLESS COMPRESSION SCREW is HWC. This falls under the Cardiovascular category.

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Other records listing Skeletal Dynamics, LLC as applicant

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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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