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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 the device name listed in this FDA 510(k) record. The listed applicant is Surgical Theater, LLC. It received FDA 510(k) clearance on 2016-06-28 under 510(k) 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. The listed applicant is Surgical Theater, LLC. The 510(k) number is K160584.

When did Surgical Navigation Advanced Platform (SNAP) receive FDA 510(k) clearance?

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

Who is the listed applicant for Surgical Navigation Advanced Platform (SNAP)?

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

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

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Other records listing Surgical Theater, LLC 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.

K252054SpineAR SNAP (SyncAR Spine)K243623SpineAR SNAP (SyncAR Spine)K213034SpineAR SNAPK201465SuRgical Planner (SRP) BrainStormK170793SuRgical Planner (SRP)

Related Devices (Code: LLZ)

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.

K262449AdvaViewADVAHEALTH SOLUTIONS, LLCK261916NeuroQuant PETCortechs Labs, Inc.K260936RadioViewAINeurocareai, Inc. (Dba Savelife.Ai)K260588Cleerly LABSCleerly, Inc.K262462TheraSphere 360™ Y-90 Management PlatformBoston Scientific CorporationK262143ImageGrid StreamVueCandelis, Inc.

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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