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FDA 510(k)

Surgical Navigation Advanced Platform (SNAP)

K-Number: K160584 · 2016-06-28

ApplicantSurgical Theater, LLC
Decision Date2016-06-28
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Surgical Navigation Advanced Platform (SNAP) is a medical device manufactured by Surgical Theater, LLC. It received FDA 510(k) clearance on 2016-06-28 under approval number K160584. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Surgical Navigation Advanced Platform (SNAP)?

Surgical Navigation Advanced Platform (SNAP) is a medical device that received FDA 510(k) clearance on 2016-06-28. It is manufactured by Surgical Theater, LLC. The 510(k) number is K160584.

When was Surgical Navigation Advanced Platform (SNAP) approved by the FDA?

Surgical Navigation Advanced Platform (SNAP) received FDA 510(k) clearance on 2016-06-28, under approval number K160584.

What company makes Surgical Navigation Advanced Platform (SNAP)?

Surgical Navigation Advanced Platform (SNAP) is manufactured by Surgical Theater, LLC.

What is the FDA product code for Surgical Navigation Advanced Platform (SNAP)?

The FDA product code for Surgical Navigation Advanced Platform (SNAP) is LLZ.

Related Clinical Trials

NCT05543941 Evaluating XPERIENCE™ Advanced Surgical Irrigation RECRUITING NCT07173309 Evaluation of Eye Gaze Sharing in the Operating Room RECRUITING NCT07174479 Eye Gaze Guidance Evaluation in Phantoms COMPLETED NCT07595835 CT-guided Percutaneous Radionuclide Therapy With 32P Microparticles in Patients With Non-progressive Locally Advanced Pancreatic Cancer RECRUITING NCT07593872 XR-Assisted PET/CT Navigation for Cervical Lymph Node Dissection in Lung Cancer NOT_YET_RECRUITING NCT07185191 Evaluation of the Safety and Performance of the Medical Device RDM36 in the Treatment of Periodontal Gingival Contraction and in Black Triangles Syndrome (BTS) RECRUITING

Related PubMed Literature

PMID: 42184430 Navigation-guided endoscopic transcerebellar approach for cyst fenestration of a dorsal brainstem lesion: illustrative case. Journal of neurosurgery. Case lessons (2026) PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025)

Other Devices by Surgical Theater, LLC

K170793SuRgical Planner (SRP)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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