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Surgical Bay Stocked with Class II Navigational Instruments

ATS Expands 510(k) Regulatory and Testing Support for Advanced Navigation Instruments 

Marietta, GA — The Applied Technical Services Family of Companies (FoC) is enhancing its comprehensive regulatory and testing capabilities to support medical device manufacturers seeking FDA 510(k) clearance for Class II devices, including surgical navigation instruments. 

Navigation technologies such as tracked bone preparation and implant delivery instruments, reference arrays, optical and electromagnetic guidance tools, and integrated software systems are widely used in orthopedic, spine, neurosurgical, and dental procedures. These platforms combine precision-engineered hardware with advanced software and real-time imaging to support procedural accuracy and consistency.  

Navigating the FDA’s 510(k) pathway requires a clearly defined regulatory framework supported by objective evidence that demonstrates safety, performance, and technological comparability. 

ATS delivers 510(k) consulting services for navigation systems and other critical medical devices, guiding manufacturers through device classification, product code confirmation, predicate identification, gap assessments, applicable standards and FDA guidance review, submission preparation, and regulatory correspondence. 

Through our integrated laboratory systems, ATS also works with manufacturers to align their regulatory strategy with applicable performance validation requirements. 

By combining regulatory insight with technical testing capabilities, ATS supports navigation instrument manufacturers in managing risk, developing well-supported submissions, and advancing efficiently through the FDA review process toward U.S. market clearance. 

For more information on our full range of 510(k) consulting services, visit our website or give us a call at +1 (888) 287-5227.