FDA 510(k)

PIT’Stop® implant

K-Number: K170688 · 2017-11-28

Decision Date2017-11-28

Product CodeHWC

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

PIT’Stop® implant is the device name listed in this FDA 510(k) record. The listed applicant is In2bones Sas. It received FDA 510(k) clearance on 2017-11-28 under 510(k) 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 PIT’Stop® implant?

PIT’Stop® implant is a medical device that received FDA 510(k) clearance on 2017-11-28. The listed applicant is In2bones Sas. The 510(k) number is K170688.

When did PIT’Stop® implant receive FDA 510(k) clearance?

PIT’Stop® implant received FDA 510(k) clearance on 2017-11-28, under 510(k) number K170688.

Who is the listed applicant for PIT’Stop® implant?

The FDA 510(k) record lists In2bones Sas as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PIT’Stop® implant?

The FDA product code for PIT’Stop® implant is HWC. This falls under the Cardiovascular category.

Other records listing In2bones Sas as applicant

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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.