FDA.reportPublic FDA data

Pro-fix™ Precision Fixation System

Primary DI
D765PFT450
Brand
Pro-fix™ Precision Fixation System
Company
Osteogenics Biomedical Inc
Model
PFT4-5
Device description
1.5 mm x 4.0 mm self-drilling titanium alloy tenting screw
Published
2021-01-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
false
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
D765PFT451PrimaryHIBCC0
D765PFT450Unit of UseHIBCC0

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
Length4Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
123853058
Device count
5
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
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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00817421023798X-GuideXNAV TECHNOLOGIES LLCDZL2026-10-14
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