FDA.reportPublic FDA data

Paradigm Drill Bit, 2.1 mm

Primary DI
00850042604281
Brand
Paradigm Drill Bit, 2.1 mm
Company
Proprio, Inc.
Model
1200025
Catalog number
1200025
Device description
Paradigm Drill Bit, 2.1 mm
Published
2025-06-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
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
K250879000
K252950000

Premarket Details#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850042604281PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850042604281008500426042818500426042810850042604281

GMDN Terms#

Term, Definition table
TermDefinition
Fluted surgical drill bit, single-useA shaft of metal with an obtuse, V-shaped cutting edge designed to be rotated to bore into bone to create a hole of the same dimension as the diameter of the shaft. This device, commonly called a "twist drill", has a cylindrical design with a double-edged cutting head that is formed from two spiralled flutes that extend the length of the insertion part of the drill. At the proximal end, it is mounted into a surgical power tool or a surgical hand drill/brace. This is a single-use 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
Manufacturing date on label
true
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
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
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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