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)

SOLANAS POSTERIOR STABILIZATION SYSTEM

K-Number: K131119 · 2013-05-21

ApplicantAlphatec Spine, Inc.
Decision Date2013-05-21
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SOLANAS POSTERIOR STABILIZATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Alphatec Spine, Inc.. It received FDA 510(k) clearance on 2013-05-21 under 510(k) number K131119. 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 2013-05-21. The listed applicant is Alphatec Spine, Inc.. The 510(k) number is K131119.

When did SOLANAS POSTERIOR STABILIZATION SYSTEM receive FDA 510(k) clearance?

SOLANAS POSTERIOR STABILIZATION SYSTEM received FDA 510(k) clearance on 2013-05-21, under 510(k) number K131119.

Who is the listed applicant for SOLANAS POSTERIOR STABILIZATION SYSTEM?

The FDA 510(k) record lists Alphatec Spine, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Alphatec Spine, Inc. 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.

K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemK253216IntraOp Alignment System; CONTOUR3D Bending SystemK253615Invictus Bands SystemK252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation)K252842SafeOp 3: Neural Informatix SystemK251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)

View all 91 devices →

Related Devices (Code: NKB)

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.

K252139Kentrospine Viktr-MIS® Pedicle screw systemRivarp Medical Pvt., Ltd.K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.K262091FRAXION Spinal Fixation SystemOrtler Global Tibbi Gerecler Anonim SirketiK262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor Sacroiliac Fixation System with NanoACTIV Surface TechnologyXenix MedicalK262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.OK260362QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration)MANTIZ Co., Ltd.

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.

↑