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)

Stryker Universal Neuro III System AXS Screw

K-Number: K171152 · 2017-05-19

ApplicantStryker
Decision Date2017-05-19
Product CodeHBW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Stryker Universal Neuro III System AXS Screw is a medical device manufactured by Stryker. It received FDA 510(k) clearance on 2017-05-19 under approval number K171152. The device is classified under product code HBW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Stryker Universal Neuro III System AXS Screw?

Stryker Universal Neuro III System AXS Screw is a medical device that received FDA 510(k) clearance on 2017-05-19. It is manufactured by Stryker. The 510(k) number is K171152.

When was Stryker Universal Neuro III System AXS Screw approved by the FDA?

Stryker Universal Neuro III System AXS Screw received FDA 510(k) clearance on 2017-05-19, under approval number K171152.

What company makes Stryker Universal Neuro III System AXS Screw?

Stryker Universal Neuro III System AXS Screw is manufactured by Stryker.

What is the FDA product code for Stryker Universal Neuro III System AXS Screw?

The FDA product code for Stryker Universal Neuro III System AXS Screw is HBW.

Related Clinical Trials

NCT05362370 Stryker PEEK Customized Implant: A Prospective Post Market Follow Up to Evaluate Safety, Performance and Effectiveness ACTIVE_NOT_RECRUITING NCT06727942 Virtual Reality-Infused Treadmill Training on Aging-Related Outcomes RECRUITING NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT07608939 Postoperative Pain After Root Canal Treatment Using Different Root Canal Sealers NOT_YET_RECRUITING NCT06087445 A User-friendly, Non-invasive Neuro-orthosis That Restores Volitionally Controlled Grasp Functions for SCI Survivors With Tetraplegia COMPLETED NCT07033130 The Performance of Different Sound Paths in Adult NeuroZti CI-users TERMINATED

Other Devices by Stryker

K161821Stryker Universal Mesh K162310XBraid TT Suture Tape K162262Tritanium® PL Cage K160955Tritanium® PL Cage K153248PEEK Customized Cranial Implant K153508Stryker CMF MEDPOR Customized Implant

View all 64 devices →

Related Devices (Code: HBW)

K231208Stryker Resorbable Fixation SystemStryker Leibinger GmbH & Co KG K251472Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System; Inion CPS 1.5 Baby Bioabsorbable Fixation SystemInion OY

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.

↑