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FDA 510(k)

ACTIVE SCREW BONE SCREW

K-Number: K121682 · 2012-10-04

ApplicantIntelligent Implant Systems, LLC
Decision Date2012-10-04
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ACTIVE SCREW BONE SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Intelligent Implant Systems, LLC. It received FDA 510(k) clearance on 2012-10-04 under 510(k) number K121682. 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 ACTIVE SCREW BONE SCREW?

ACTIVE SCREW BONE SCREW is a medical device that received FDA 510(k) clearance on 2012-10-04. The listed applicant is Intelligent Implant Systems, LLC. The 510(k) number is K121682.

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

ACTIVE SCREW BONE SCREW received FDA 510(k) clearance on 2012-10-04, under 510(k) number K121682.

Who is the listed applicant for ACTIVE SCREW BONE SCREW?

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

What is the FDA product code for ACTIVE SCREW BONE SCREW?

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

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Other records listing Intelligent Implant Systems, LLC as applicant

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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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