HBS2 Headless Bone Screw
K-Number: K171628 · 2018-01-12
ApplicantStuckenbrock Medizintechnik GmbH
Decision Date2018-01-12
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
HBS2 Headless Bone Screw is a medical device manufactured by Stuckenbrock Medizintechnik GmbH. It received FDA 510(k) clearance on 2018-01-12 under approval number K171628. 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 HBS2 Headless Bone Screw?
HBS2 Headless Bone Screw is a medical device that received FDA 510(k) clearance on 2018-01-12. It is manufactured by Stuckenbrock Medizintechnik GmbH. The 510(k) number is K171628.
When was HBS2 Headless Bone Screw approved by the FDA?
HBS2 Headless Bone Screw received FDA 510(k) clearance on 2018-01-12, under approval number K171628.
What company makes HBS2 Headless Bone Screw?
HBS2 Headless Bone Screw is manufactured by Stuckenbrock Medizintechnik GmbH.
What is the FDA product code for HBS2 Headless Bone Screw?
The FDA product code for HBS2 Headless Bone 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.