FDA.reportPublic FDA data

Pro-fix™ Precision Fixation System

Primary DI
D765PFB140
Brand
Pro-fix™ Precision Fixation System
Company
Osteogenics Biomedical Inc
Model
PFB14
Device description
1.5 mm x 14.0 mm self-tapping titanium alloy bone fixation screwhttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#
Published
2021-01-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
DZLScrew, Fixation, Intraosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZLScrew, Fixation, IntraosseousDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K093719000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K093719000PRO-FIX PRECISION FIXATION SYSTEM MODEL PFM#, PFB#, PFT#Osteogenics Biomedical, Inc.2010-03-01DZL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D765PFB140PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Craniofacial bone screw, non-bioabsorbable, non-sterileA small, non-sterile, threaded rod with a slotted head intended to be implanted or inserted short-term in craniofacial bone (including the maxilla and/or mandible) for fracture treatment or for the fixation of transplanted bone chips and/or small grafts (e.g., during an intraoral bone augmentation procedure). The device may be self-drilling/self-tapping and is made of a material that is not chemically degraded or absorbed via natural body processes [e.g., implant grade metal such as surgical steel, titanium (Ti)]. This device is intended to be sterilized prior to use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length14Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
123853058
Device count
1
DM exempt
true
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
D765ZL1000ZCOREZL1002016-04-29
D765ZL2000ZCOREZL2002016-04-29
D765ZS0500ZCOREZS0502016-04-29
D765ZS1000ZCOREZS1002016-04-29
D765ZS2000ZCOREZS2002016-04-29
D765ZS4000ZCOREZS4002016-04-29
D765ZXSOCKET100ZCORE™ EXPANDZXSOCKET-102025-04-14
D765ZXSOCKET50ZCORE™ EXPANDZXSOCKET-52025-04-14
D765ZY0250ZCOREZY0252016-04-29
D765ZY025M20ZCOREZY0252018-12-07
D765ZY0500ZCOREZY0502016-04-29
D765ZY050M20ZCOREZY0502018-12-07
D765ZY1000ZCOREZY1002016-04-29
D765ZXSOCKET10ZCORE™ EXPANDZXSOCKET-12025-04-14
D765ZXSINUSL0ZCORE™ EXPANDZXSINUSL2021-06-25
D765ZXSINUSS0ZCORE™ EXPANDZXSINUSS2021-06-25
D765ZXSOCKET0ZCORE™ EXPANDZXSOCKET2021-06-25
D765ZF0500ZCORE FORMZF0502021-03-12
D765ZF1000ZCORE FORMZF1002021-03-12
D765ZF2000ZCORE FORMZF2002021-03-12

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Primary DI, Brand, Company table
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00817421023781X-GuideXNAV TECHNOLOGIES LLCDZL2026-10-14
00817421023798X-GuideXNAV TECHNOLOGIES LLCDZL2026-10-14
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