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)

DYMAXEON SPINE SYSTEM

K-Number: K121786 · 2012-11-05

ApplicantB2b Spine Pty, Ltd.
Decision Date2012-11-05
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DYMAXEON SPINE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is B2b Spine Pty, Ltd.. It received FDA 510(k) clearance on 2012-11-05 under 510(k) number K121786. 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 DYMAXEON SPINE SYSTEM?

DYMAXEON SPINE SYSTEM is a medical device that received FDA 510(k) clearance on 2012-11-05. The listed applicant is B2b Spine Pty, Ltd.. The 510(k) number is K121786.

When did DYMAXEON SPINE SYSTEM receive FDA 510(k) clearance?

DYMAXEON SPINE SYSTEM received FDA 510(k) clearance on 2012-11-05, under 510(k) number K121786.

Who is the listed applicant for DYMAXEON SPINE SYSTEM?

The FDA 510(k) record lists B2b Spine Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DYMAXEON SPINE SYSTEM?

The FDA product code for DYMAXEON SPINE 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

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.OK253943Tiger 2 SystemZavation Medical Products, 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.

↑