FDA.reportPublic FDA data

Paradigm

Primary DI
00850042604014
Brand
Paradigm
Company
Proprio, Inc.
Model
1100006
Catalog number
1100006
Device description
Paradigm System Cart
Published
2025-03-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OLOOrthopedic Stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLOOrthopedic Stereotaxic InstrumentNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243258000
K250879000
K252950000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243258000Paradigm SystemProprio, Inc.2025-02-21OLO
K250879000Paradigm SystemProprio, Inc.2025-06-04OLO
K252950000Paradigm SystemProprio, Inc.2025-12-15OLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850042604014PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850042604014008500426040148500426040140850042604014

GMDN Terms#

Term, Definition table
TermDefinition
Optical surgical navigation device tracking systemA mobile assembly of electrically-powered devices intended to provide a physician with optical tools to track manual surgical instruments and locate anatomical structures with respect to pre-acquired images (e.g., CT/MRI scan) or real-time data [e.g., endoscopic, ultrasound (US)] during computer assisted surgery (CAS). It consists of a workstation with controls/display, a position/movement tracking camera, adaptors, and sensors/spatial markers designed to be attached to the patient and instruments. It is used for multiple surgical procedures (e.g., craniotomy, tumour resection) in various fields [e.g., ear/nose/throat (ENT), neurosurgical, or craniomaxillofacial (CMF) surgery].

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
206-848-6303customerservice@propriovision.com

Regulatory Flags#

DUNS number
010254854
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850042604366Paradigm Foot Switch110000811000082026-01-13
00850042604236 Paradigm Navigated Drill Guide Case Tray120002212000222025-06-09
00850042604243Paradigm Navigated Drill Guide Case Lid120002312000232025-06-09
00850042604274Paradigm Navigated Drill Guide120002412000242025-06-09
00850042604281Paradigm Drill Bit, 2.1 mm120002512000252025-06-09
00850042604298Paradigm Drill Bit, 3.0 mm120002612000262025-06-09
00850042604304Paradigm Depth Cannula, 2mm120002712000272025-06-09
00850042604311Paradigm Drill Guide Trocar120002812000282025-06-09
00850042604328Paradigm Depth Cannula, 5mm120003012000302025-06-09
00850042604335Paradigm Navigated Drill Guide Set120002012000202025-06-09
00850042604342Paradigm Navigated Drill Guide Case Assembly120002112000212025-06-09
00850042604021Paradigm120000912000092025-03-21
00850042604113Paradigm120001112000112025-03-21
00850042604120Paradigm120001212000122025-03-21
00850042604137Paradigm120002912000292025-03-21
00850042604144Paradigm120001012000102025-03-21
00850042604151Paradigm120000812000082025-03-21
00850042604168Paradigm120001312000132025-03-21
00850042604175Paradigm120001412000142025-03-21
00850042604182Paradigm120001512000152025-03-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327594829Common Shoulder DriverMAKO SURGICAL CORP.OLO2026-05-21
07613327595543MakoMAKO SURGICAL CORP.OLO2026-05-21
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07640221373052PERLA NAVSpineArt SAOLO2026-05-07
07640221373069PERLA NAVSpineArt SAOLO2026-05-07
07640221373113PERLA NAVSpineArt SAOLO2026-05-07
07640221373120PERLA NAVSpineArt SAOLO2026-05-07
07640221373137PERLA NAVSpineArt SAOLO2026-05-07
07640221373144PERLA NAVSpineArt SAOLO2026-05-07
07640221373151PERLA NAVSpineArt SAOLO2026-05-07
07640221373168PERLA NAVSpineArt SAOLO2026-05-07
07640221373175PERLA NAVSpineArt SAOLO2026-05-07
07640221373182PERLA NAVSpineArt SAOLO2026-05-07
07640221373199PERLA NAVSpineArt SAOLO2026-05-07
07640221373205PERLA NAVSpineArt SAOLO2026-05-07
07640221373212PERLA NAVSpineArt SAOLO2026-05-07
07640221373229PERLA NAVSpineArt SAOLO2026-05-07
07640221373236PERLA NAVSpineArt SAOLO2026-05-07
07640221373243PERLA NAVSpineArt SAOLO2026-05-07
07640221373250PERLA NAVSpineArt SAOLO2026-05-07
07640221373267PERLA NAVSpineArt SAOLO2026-05-07
07640221373274PERLA NAVSpineArt SAOLO2026-05-07
07640221373281PERLA NAVSpineArt SAOLO2026-05-07
07640221373298PERLA NAVSpineArt SAOLO2026-05-07
07640221373304PERLA NAVSpineArt SAOLO2026-05-07
07640221373311PERLA NAVSpineArt SAOLO2026-05-07
07640221373328PERLA NAVSpineArt SAOLO2026-05-07
07640221373335PERLA NAVSpineArt SAOLO2026-05-07
07640221373601PERLA NAVSpineArt SAOLO2026-05-07
07640221373618PERLA NAVSpineArt SAOLO2026-05-07