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FDA 510(k)

Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw

K-Number: K231819 · 2023-09-05

ApplicantInnovate Orthopaedics Limited
Decision Date2023-09-05
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw is a medical device manufactured by Innovate Orthopaedics Limited. It received FDA 510(k) clearance on 2023-09-05 under approval number K231819. 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 Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw?

Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw is a medical device that received FDA 510(k) clearance on 2023-09-05. It is manufactured by Innovate Orthopaedics Limited. The 510(k) number is K231819.

When was Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw approved by the FDA?

Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw received FDA 510(k) clearance on 2023-09-05, under approval number K231819.

What company makes Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw?

Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw is manufactured by Innovate Orthopaedics Limited.

What is the FDA product code for Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw?

The FDA product code for Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw is HWC. This falls under the Cardiovascular category.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT07599124 Effectiveness of Light Therapy Across Seasons COMPLETED NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT07568288 The Effectiveness of High-intensity Laser Therapy After Arthroscopic Shoulder Rotator Cuff Repair. NOT_YET_RECRUITING NCT07247825 Efficacy of Therapeutic Percutaneous Electrolysis vs Laser Therapy in Supraspinatus Tendinopathy. RECRUITING NCT06024304 InterTAN: Integrated Dual Screw Design Improve Biomechanics/Function Following Fixation Surgery RECRUITING

Related PubMed Literature

PMID: 38493931 Establishing finite element model credibility of a pedicle screw system under compression-bending: An end-to-end example of the ASME V&V 40 standard. Methods (San Diego, Calif.) (2024) PMID: 30035086 Translational research of one dynamic hip screw system-from the SCI to the FDA. Journal of orthopaedic translation (2016)

Other Devices by Innovate Orthopaedics Limited

K212547Quick-Start Screws

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.

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