FDA.reportPublic FDA data

SpineAR SNAP

Primary DI
00860003884126
Brand
SpineAR SNAP
Company
SURGICAL THEATER LLC
Model
SpineAR
Device description
SpineAR Surgical Navigation Advanced Platform (SNAP) Operating Room System
Published
2023-06-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LLZSystem, Image Processing, Radiological
OLOOrthopedic Stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2
OLOOrthopedic Stereotaxic InstrumentNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K213034000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213034000SpineAR SNAPSurgical Theater, Inc.2022-09-29SBF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860003884126PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860003884126008600038841268600038841260860003884126

GMDN Terms#

Term, Definition table
TermDefinition
Surgical planning/navigation-enhancement systemA mobile assembly of mains electricity (AC-powered) devices intended for both pre- and intraoperative applications to: 1) process medical imaging data to create a patient-specific, three-dimensional (3-D) model to enable a surgeon to plan/prepare for a surgical procedure; and 2) connect to a separate surgical navigation system to extract and display real-time surgical navigation information (e.g., navigation pointer) within the same 3-D model during surgery. It includes hardware [e.g., personal computer (PC), monitors, medical grade keyboard) and dedicated software. It is capable of collecting patient demographics, which may be anonymised.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
330-472-6520information@surgicaltheater.com

Regulatory Flags#

DUNS number
071341647
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00863157000336SRPSRP2016-09-23
00863157000305SNAP ORSNAP2016-09-23
00860003884102SyncAR SNAPSyncAR2020-06-01
00860003884119SRP BrainStormBrainStorm2020-12-08
00863157000367SNAP Mini DesktopVR MSNAP2017-01-04
00863157000374SNAP Patient EngagementPE SNAP2017-03-27
00863157000312SNAP DesktopVR SNAP2016-09-23
00863157000329Endo SNAPEndo SNAP2016-09-13
00863157000343Notebook Clinic ViewerNotebook2016-09-23
00863157000350All-in-One Clinic ViewerAll-in-One2016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06938396401528SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
06938396401559SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
06938396401566SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
06938396401597SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
06938396401603SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
06938396401634SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
06938396401658SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
06938396401702SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
06938396401719SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
06938396410124SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
07630345700551NextAR TSA PlatformMedacta International SAOLO2026-07-10
00810180351720360CASKICO KNEE INNOVATION COMPANY PTY LIMITEDOLO2026-07-09
04260483290305MeVis AVM ContourMeVis Medical Solutions AGLLZ2026-07-09
10705034647302CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647319CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647326CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647333CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647340CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647357CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647364CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647371CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647388CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647395CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647418CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647425CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647432CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647449CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647456CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647470CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647487CROSSNAV CONDUITMedos International SàrlOLO2026-07-09