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

FDA 510(k)

OrthoSolutions 'System26' Bone Screws

K-Number: K163489 · 2017-03-08

ApplicantOrtho Solutions UK Limited
Decision Date2017-03-08
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OrthoSolutions 'System26' Bone Screws is a medical device manufactured by Ortho Solutions UK Limited. It received FDA 510(k) clearance on 2017-03-08 under approval number K163489. 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 OrthoSolutions 'System26' Bone Screws?

OrthoSolutions 'System26' Bone Screws is a medical device that received FDA 510(k) clearance on 2017-03-08. It is manufactured by Ortho Solutions UK Limited. The 510(k) number is K163489.

When was OrthoSolutions 'System26' Bone Screws approved by the FDA?

OrthoSolutions 'System26' Bone Screws received FDA 510(k) clearance on 2017-03-08, under approval number K163489.

What company makes OrthoSolutions 'System26' Bone Screws?

OrthoSolutions 'System26' Bone Screws is manufactured by Ortho Solutions UK Limited.

What is the FDA product code for OrthoSolutions 'System26' Bone Screws?

The FDA product code for OrthoSolutions 'System26' Bone Screws is HWC. This falls under the Cardiovascular category.

Related Devices (Code: HWC)

K161259KLS Martin Cannulated Headless ScrewsKLS Martin L.P. K1609464.0 and 6.5 Cancellous Bone Screw and WasherSmv Scientific K161778ToeTac™ 10° Hammertoe Fixation SystemRestore Surgical, LLC Dba Instratek K161597Tyber Medical BioTy® Nanotopography Trauma ScrewTyber Medical, LLC K160791AmorChem Titanium Porous Fixation DeviceAmorchem Holdings, Inc. K161449HammerTech Fixation SystemFusion Orthopedics, LLC

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.

↑