Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 the device name listed in this FDA 510(k) record. The listed applicant is Smv Scientific. It received FDA 510(k) clearance on 2016-12-05 under 510(k) 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. The listed applicant is Smv Scientific. The 510(k) number is K160946.

When did 4.0 and 6.5 Cancellous Bone Screw and Washer receive FDA 510(k) clearance?

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

Who is the listed applicant for 4.0 and 6.5 Cancellous Bone Screw and Washer?

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

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.

Other records listing Smv Scientific as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K170021SMV Scientific Cannulated ScrewsK160603SMV Scientific Schanz Screws

Related Devices (Code: HWC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262075Lapidus Screw KitRelja Innovations, LLCK260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.K253108VEOFIX Snap Off ScrewSteps OrthoK261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLCK261241TriMed Compression ScrewsTriMed, Inc.K254215Arthrex Beaming SystemArthrex, Inc.

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.

↑