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FDA 510(k)

4.0 and 6.5 Cancellous Bone Screw and Washer

K-Number: K160946 · 2016-12-05

ApplicantSmv Scientific
Decision Date2016-12-05
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

4.0 and 6.5 Cancellous Bone Screw and Washer is a medical device manufactured by Smv Scientific. It received FDA 510(k) clearance on 2016-12-05 under approval number K160946. 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 4.0 and 6.5 Cancellous Bone Screw and Washer?

4.0 and 6.5 Cancellous Bone Screw and Washer is a medical device that received FDA 510(k) clearance on 2016-12-05. It is manufactured by Smv Scientific. The 510(k) number is K160946.

When was 4.0 and 6.5 Cancellous Bone Screw and Washer approved by the FDA?

4.0 and 6.5 Cancellous Bone Screw and Washer received FDA 510(k) clearance on 2016-12-05, under approval number K160946.

What company makes 4.0 and 6.5 Cancellous Bone Screw and Washer?

4.0 and 6.5 Cancellous Bone Screw and Washer is manufactured by Smv Scientific.

What is the FDA product code for 4.0 and 6.5 Cancellous Bone Screw and Washer?

The FDA product code for 4.0 and 6.5 Cancellous Bone Screw and Washer 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.

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