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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 the device name listed in this FDA 510(k) record. The listed applicant is Rmr Ortho, LLC. It received FDA 510(k) clearance on 2024-01-12 under 510(k) 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. The listed applicant is Rmr Ortho, LLC. The 510(k) number is K232990.

When did A’TOMIC™ Nitinol Fixation System receive FDA 510(k) clearance?

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

Who is the listed applicant for A’TOMIC™ Nitinol Fixation System?

The FDA 510(k) record lists Rmr Ortho, LLC as the applicant. This does not by itself establish the device manufacturer.

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 Devices (Code: JDR)

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.

K261121Megalodon Dynamic Compression SystemParagon 28, Inc.K250712Linkt Compression Staple SystemTrax SurgicalK243888Medline UNITE® REFLEX® Hybrid Nitinol Implant SystemMedline Industries, LPK243742Arthrex DynaNite Nitinol StaplesArthrex, Inc.K243658TMC Compression Implant SystemTreace Medical ConceptsK242415TMC Compression Implant SystemTreace Medical Concepts

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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