FDA.reportPublic FDA data

Paradigm

Primary DI
00850042604212
Brand
Paradigm
Company
Proprio, Inc.
Model
1200018
Catalog number
1200018
Device description
Paradigm DRF Ratcheting Clamp
Published
2025-03-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

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
00850042604212PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850042604212008500426042128500426042120850042604212

GMDN Terms#

Term, Definition table
TermDefinition
Bone holding forcepsA manual surgical instrument designed to grasp and hold a bone during an open surgical procedure. It is typically strongly constructed with a scissors-like design, which may or may not be self-retaining, and with ring handles or curved shank handles. It is made of high-grade stainless steel and is available in various sizes. The working end can have a wide variety of jaws designs, e.g., curved serrated jaws, straight toothed jaws, or profiled wrench-like jaws with grooves to provide extra grip of the bone. 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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
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
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
00850042604021Paradigm120000912000092025-03-21

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810076335322MomentumUlrich Medical Usa, Inc.OLO2026-09-25
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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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