FDA.reportPublic FDA data

Pro-fix™ Precision Fixation System

Primary DI
D765PFMF51
Brand
Pro-fix™ Precision Fixation System
Company
Osteogenics Biomedical Inc
Model
PFMF-5
Device description
1.5 mm x 3.0 mm self-drilling titanium alloy membrane fixation screw
Published
2021-01-13
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
D765PFMF51PrimaryHIBCC0
D765PFMF50Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Craniofacial bone screw, non-bioabsorbableA small, threaded rod with a slotted and/or polygonal (e.g., hexagonal) head intended to be implanted in craniofacial bone (including the maxilla and/or mandible) for fracture fixation by direct interfragmentary stabilization of bone or by screwing plates in place; it may also be intended for transplanted bone fixation. It 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 titanium (Ti)]. Its uses include repair of orbital fractures and fractures around the cranial sinuses, paediatric reconstructive surgery, craniotomy flap fixation, bone augmentation procedures.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length3Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
123853058
Device count
5
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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