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)

MINI VARIABLE SYSTEM

K-Number: K111041 · 2011-06-06

ApplicantOrthohelix Surgical Designs, Inc.
Decision Date2011-06-06
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MINI VARIABLE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Orthohelix Surgical Designs, Inc.. It received FDA 510(k) clearance on 2011-06-06 under 510(k) number K111041. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MINI VARIABLE SYSTEM?

MINI VARIABLE SYSTEM is a medical device that received FDA 510(k) clearance on 2011-06-06. The listed applicant is Orthohelix Surgical Designs, Inc.. The 510(k) number is K111041.

When did MINI VARIABLE SYSTEM receive FDA 510(k) clearance?

MINI VARIABLE SYSTEM received FDA 510(k) clearance on 2011-06-06, under 510(k) number K111041.

Who is the listed applicant for MINI VARIABLE SYSTEM?

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

What is the FDA product code for MINI VARIABLE SYSTEM?

The FDA product code for MINI VARIABLE SYSTEM is HRS.

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 Orthohelix Surgical Designs, 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.

K132591MAXLOCK EXTREME SYSTEMK130832ORTHOHELIX STAPLE SYSTEMK131324MAXTORQUE SCREW SYSTEMK123203MAXLOCK EXTREME SYSTEM MODEL MXLK122005MAXLOCK EXTREME SYSTEMK121437MINI MAXLOCK EXTREME PLATING SYSTEM

View all 21 devices →

Related Devices (Code: HRS)

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.

K261892ProRib Fixation SystemCosta Surgical, Inc.K262098EnHAnce PEEK Bunion SystemNvision Biomedical TechnologiesK262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.K261647Tempo Plating System; Ultra Compression Screw SystemPace SurgicalK261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See Catalog);FRAXION Mini Plate System (Various - See Catalog);FRAXION Bone Screw System (Various - See Catalog)Ortler Global Tibbi Gerecler Anonim SirketiK262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.

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.

↑