ICONN Campbell Interference Screw
K-Number: K180670 · 2018-12-07
ApplicantIconn Orthopedics, LLC
Decision Date2018-12-07
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
ICONN Campbell Interference Screw is a medical device manufactured by Iconn Orthopedics, LLC. It received FDA 510(k) clearance on 2018-12-07 under approval number K180670. 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 ICONN Campbell Interference Screw?
ICONN Campbell Interference Screw is a medical device that received FDA 510(k) clearance on 2018-12-07. It is manufactured by Iconn Orthopedics, LLC. The 510(k) number is K180670.
When was ICONN Campbell Interference Screw approved by the FDA?
ICONN Campbell Interference Screw received FDA 510(k) clearance on 2018-12-07, under approval number K180670.
What company makes ICONN Campbell Interference Screw?
ICONN Campbell Interference Screw is manufactured by Iconn Orthopedics, LLC.
What is the FDA product code for ICONN Campbell Interference Screw?
The FDA product code for ICONN Campbell Interference Screw is HWC. This falls under the Cardiovascular category.
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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.