FDA.reportPublic FDA data

Paradigm

Primary DI
00850042604168
Brand
Paradigm
Company
Proprio, Inc.
Model
1200013
Catalog number
1200013
Device description
Paradigm DRF L-Rod, 50 mm
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
00850042604168PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850042604168008500426041688500426041680850042604168

GMDN Terms#

Term, Definition table
TermDefinition
Surgical optical-tracking spatial marker, reusableA non-powered, noninvasive component of a surgical navigation and/or device tracking system (e.g., computer-assisted surgical ultrasound system, surgical microscope) intended for preoperative and/or intraoperative use to function as an optical reference to enable spatial registration/tracking of the position/movement/size of a patient, another marker, and/or surgical instrument (e.g., stereotactic surgery probe). It may be attached to the patient, another marker or surgical instrument, and may contain features (e.g., reflective spheres, contrast patterns) detectable by a tracking camera. Procedural supportive devices (e.g., drapes) may be included with the device. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
010254854
Device count
1
Lot or batch
true
Sterilization required before use
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
00850042604014Paradigm110000611000062025-03-21
00850042604021Paradigm120000912000092025-03-21
00850042604113Paradigm120001112000112025-03-21
00850042604120Paradigm120001212000122025-03-21
00850042604137Paradigm120002912000292025-03-21
00850042604144Paradigm120001012000102025-03-21
00850042604151Paradigm120000812000082025-03-21
00850042604175Paradigm120001412000142025-03-21
00850042604182Paradigm120001512000152025-03-21

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Primary DI, Brand, Company table
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00840493423241RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
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00840493423401RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423418RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423425RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423432RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423449RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
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