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FDA 510(k)

SLIC SCREW REPAIR SYSTEM

K-Number: K111608 · 2011-08-29

ApplicantAcumed, LLC
Decision Date2011-08-29
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SLIC SCREW REPAIR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Acumed, LLC. It received FDA 510(k) clearance on 2011-08-29 under 510(k) number K111608. 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 SLIC SCREW REPAIR SYSTEM?

SLIC SCREW REPAIR SYSTEM is a medical device that received FDA 510(k) clearance on 2011-08-29. The listed applicant is Acumed, LLC. The 510(k) number is K111608.

When did SLIC SCREW REPAIR SYSTEM receive FDA 510(k) clearance?

SLIC SCREW REPAIR SYSTEM received FDA 510(k) clearance on 2011-08-29, under 510(k) number K111608.

Who is the listed applicant for SLIC SCREW REPAIR SYSTEM?

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

What is the FDA product code for SLIC SCREW REPAIR SYSTEM?

The FDA product code for SLIC SCREW REPAIR SYSTEM is HWC. This falls under the Cardiovascular category.

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Other records listing Acumed, 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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