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FDA 510(k)

Solanas® Posterior Stabilization System

K-Number: K173522 · 2017-11-30

ApplicantAlphatec Spine, Inc.
Decision Date2017-11-30
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Solanas® Posterior Stabilization System is a medical device manufactured by Alphatec Spine, Inc.. It received FDA 510(k) clearance on 2017-11-30 under approval number K173522. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Solanas® Posterior Stabilization System?

Solanas® Posterior Stabilization System is a medical device that received FDA 510(k) clearance on 2017-11-30. It is manufactured by Alphatec Spine, Inc.. The 510(k) number is K173522.

When was Solanas® Posterior Stabilization System approved by the FDA?

Solanas® Posterior Stabilization System received FDA 510(k) clearance on 2017-11-30, under approval number K173522.

What company makes Solanas® Posterior Stabilization System?

Solanas® Posterior Stabilization System is manufactured by Alphatec Spine, Inc..

What is the FDA product code for Solanas® Posterior Stabilization System?

The FDA product code for Solanas® Posterior Stabilization System is NKB.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT05391828 Persona MC vs PS RCT With ROSA RECRUITING NCT05508360 "Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2) RECRUITING NCT05489822 PMCF Study to Evaluate the VERTICALE® Cervical System in Spine Surgery According to Its Intended Use. TERMINATED NCT07527299 A Study of VARIPULSE Catheter in Participants With Persistent Atrial Fibrillation Undergoing Pulmonary Vein and Superior Vena Cava Isolation NOT_YET_RECRUITING NCT02839850 14022 ATTUNE Cementless RP Clinical Performance Evaluation ACTIVE_NOT_RECRUITING

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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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