I.B.S. 2.0 Osteosynthesis screw
K-Number: K160174 · 2016-10-06
ApplicantIn2bones Sas
Decision Date2016-10-06
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
I.B.S. 2.0 Osteosynthesis screw is a medical device manufactured by In2bones Sas. It received FDA 510(k) clearance on 2016-10-06 under approval 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. It is manufactured by In2bones Sas. The 510(k) number is K160174.
When was I.B.S. 2.0 Osteosynthesis screw approved by the FDA?
I.B.S. 2.0 Osteosynthesis screw received FDA 510(k) clearance on 2016-10-06, under approval number K160174.
What company makes I.B.S. 2.0 Osteosynthesis screw?
I.B.S. 2.0 Osteosynthesis screw is manufactured by In2bones Sas.
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
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.