FDA.reportPublic FDA data

Paradigm

Primary DI
00850042604106
Brand
Paradigm
Company
Proprio, Inc.
Model
1100004
Catalog number
1100004
Device description
Paradigm External Monitor Stand
Published
2023-05-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K222291000
K243258000
K250879000
K252950000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222291000Paradigm SystemProprio, Inc.2023-04-21OLO
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
00850042604106PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850042604106008500426041068500426041060850042604106

GMDN Terms#

Term, Definition table
TermDefinition
Image display unit, colourAn electrically-powered visual display unit (VDU), commonly known as a screen or a monitor, designed for displaying graphical information under program control in colour, e.g., measured values or images from other devices. Colour is necessary when separating the information of multiple parameters making it easier for the user to read the values. A keyboard may be connected to the unit for interactive manipulation of the data by an operator. This group of devices is the product identifier for the monitor only, which will not include the device(s) from which the data is generated and includes different screen technologies, e.g., cathode-ray tube (CRT) or liquid crystal display (LCD).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
2068486303customerservice@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
00850042604311Paradigm Drill Guide Trocar120002812000282025-06-09
00850042604014Paradigm110000611000062025-03-21
00850042604168Paradigm120001312000132025-03-21
00850042604175Paradigm120001412000142025-03-21
00850042604182Paradigm120001512000152025-03-21
00850042604199Paradigm120001612000162025-03-21
00850042604205Paradigm120001712000172025-03-21
00850042604212Paradigm120001812000182025-03-21
00850042604007Paradigm110000111000032023-05-05
00850042604045Paradigm120000212000022023-05-05
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
00850042604328Paradigm Depth Cannula, 5mm120003012000302025-06-09
00850042604335Paradigm Navigated Drill Guide Set120002012000202025-06-09
00850042604342Paradigm Navigated Drill Guide Case Assembly120002112000212025-06-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810055525225Onyx 4.5 mm Navigated Cannulated TapSi-Bone Inc.OLO2026-09-30
00810055525232Onyx 5.5mm Navigated Cannulated TapSi-Bone Inc.OLO2026-09-30
00810055525249Onyx 6.5mm Navigated Cannulated TapSi-Bone Inc.OLO2026-09-30
00810055525256Onyx 7.5mm Navigated Cannulated TapSi-Bone Inc.OLO2026-09-30
00810055525263Onyx 4.5 mm Navigated Awl Tip TapSi-Bone Inc.OLO2026-09-30
00810055525270Onyx 5.5 mm Navigated Awl Tip TapSi-Bone Inc.OLO2026-09-30
00810055525287Onyx 6.5 mm Navigated Awl Tip TapSi-Bone Inc.OLO2026-09-30
00810055525294Onyx 7.5 mm Navigated Awl Tip TapSi-Bone Inc.OLO2026-09-30
00810055525720Onyx Navigated Locking DriverSi-Bone Inc.OLO2026-09-30
00810055525966Onyx Navigated Locking Driver, CannulatedSi-Bone Inc.OLO2026-09-30
00810055526284Onyx iGPS Awl Tip Tap 4.5mmSi-Bone Inc.OLO2026-09-30
00810055526291Onyx iGPS Awl Tip Tap 5.5mmSi-Bone Inc.OLO2026-09-30
00810055526307Onyx iGPS Awl Tip Tap 6.5mmSi-Bone Inc.OLO2026-09-30
00810055526314Onyx iGPS Awl Tip Tap 7.5mmSi-Bone Inc.OLO2026-09-30
00810055526321Onyx iGPS DriverSi-Bone Inc.OLO2026-09-30
00810076335322MomentumUlrich Medical Usa, Inc.OLO2026-09-25
00810131884055TiLink-L Rescue Drill GuideSurgentec, LLCOLO2026-09-25
00810131884062TiLink-L Rescue DilatorSurgentec, LLCOLO2026-09-25
00810131884079TiLink-L Rescue Impact CapSurgentec, LLCOLO2026-09-25
00810131884086TiLink-L Rescue screw Drill bit – 10.5mmSurgentec, LLCOLO2026-09-25
00810131884857TiLink-L Sterilization Tray – Double StackSurgentec, LLCOLO2026-09-25
00810131884864TiLink-L Rescue CaddySurgentec, LLCOLO2026-09-25
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07613327460704Navigation EnabledStryker CorporationOLO2019-10-16
07613327460711Navigation EnabledStryker CorporationOLO2019-10-16
07613327460728Navigation EnabledStryker CorporationOLO2019-10-16
07613327460735Navigation EnabledStryker CorporationOLO2019-10-16