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)

A’TOMIC™ Nitinol Fixation System

K-Number: K232990 · 2024-01-12

ApplicantRmr Ortho, LLC
Decision Date2024-01-12
Product CodeJDR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

A’TOMIC™ Nitinol Fixation System is a medical device manufactured by Rmr Ortho, LLC. It received FDA 510(k) clearance on 2024-01-12 under approval number K232990. The device is classified under product code JDR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the A’TOMIC™ Nitinol Fixation System?

A’TOMIC™ Nitinol Fixation System is a medical device that received FDA 510(k) clearance on 2024-01-12. It is manufactured by Rmr Ortho, LLC. The 510(k) number is K232990.

When was A’TOMIC™ Nitinol Fixation System approved by the FDA?

A’TOMIC™ Nitinol Fixation System received FDA 510(k) clearance on 2024-01-12, under approval number K232990.

What company makes A’TOMIC™ Nitinol Fixation System?

A’TOMIC™ Nitinol Fixation System is manufactured by Rmr Ortho, LLC.

What is the FDA product code for A’TOMIC™ Nitinol Fixation System?

The FDA product code for A’TOMIC™ Nitinol Fixation System is JDR.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT07277946 AtraUmatic Laparoscopic HerNia Repair Clinical Investigation to Evaluate the Safety and Performance of The ECLIPSIUM System for Mesh Fixation IDE RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT07245719 Stryker Universal Midface and Upper-Face Fixation System: A Retrospective Post Market Follow Up COMPLETED NCT07485829 Zimmer Biomet-RibFix Titan RECRUITING NCT07079774 TrueLok Elevate PMCF Study RECRUITING

Related Devices (Code: JDR)

K161426NeoSpan Compression Staple Impant w/instrumentsIn2bones USA, LLC K160813EasyStepStryker GmbH K153622First Ray Internal Bone Staple SystemFirst Ray, LLC K153770OS2(R)-VP Varisation StapleIn2bones Sas K153395OS2-C Compression StapleIn2bones Sas K153129dynaMX Tabbed StapleMx Orthopedics, Corp.

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.

↑