PITStop® implant
K-Number: K170688 · 2017-11-28
ApplicantIn2bones Sas
Decision Date2017-11-28
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
PITStop® implant is a medical device manufactured by In2bones Sas. It received FDA 510(k) clearance on 2017-11-28 under approval number K170688. 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 PITStop® implant?
PITStop® implant is a medical device that received FDA 510(k) clearance on 2017-11-28. It is manufactured by In2bones Sas. The 510(k) number is K170688.
When was PITStop® implant approved by the FDA?
PITStop® implant received FDA 510(k) clearance on 2017-11-28, under approval number K170688.
What company makes PITStop® implant?
PITStop® implant is manufactured by In2bones Sas.
What is the FDA product code for PITStop® implant?
The FDA product code for PITStop® implant 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.