FDA 510(k)

I.B.S. 2.0 Osteosynthesis screw

K-Number: K160174 · 2016-10-06

Decision Date2016-10-06

Product CodeHWC

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

I.B.S. 2.0 Osteosynthesis screw is the device name listed in this FDA 510(k) record. The listed applicant is In2bones Sas. It received FDA 510(k) clearance on 2016-10-06 under 510(k) number K160174. 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 I.B.S. 2.0 Osteosynthesis screw?

I.B.S. 2.0 Osteosynthesis screw is a medical device that received FDA 510(k) clearance on 2016-10-06. The listed applicant is In2bones Sas. The 510(k) number is K160174.

When did I.B.S. 2.0 Osteosynthesis screw receive FDA 510(k) clearance?

I.B.S. 2.0 Osteosynthesis screw received FDA 510(k) clearance on 2016-10-06, under 510(k) number K160174.

Who is the listed applicant for I.B.S. 2.0 Osteosynthesis screw?

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 I.B.S. 2.0 Osteosynthesis screw?

The FDA product code for I.B.S. 2.0 Osteosynthesis screw is HWC. This falls under the Cardiovascular category.

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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.