FDA.reportPublic FDA data

Pro-fix™ Precision Fixation System

Primary DI
D765PFB1251
Brand
Pro-fix™ Precision Fixation System
Company
Osteogenics Biomedical Inc
Model
PFB12-5
Device description
1.5 mm x 12.0 mm self-tapping titanium alloy bone fixation screw
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
D765PFB1251PrimaryHIBCC0
D765PFB1250Unit 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
Length12Millimeter

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
D765CS0523BK0Cytoplast™ PTFE SutureCS0523BK2019-02-22
D765RPM200ATCM0RPM™ Reinforced PTFE MeshRPM200ATCM2020-07-27
D765GC3019450X-Gut™ Chromic Gut SutureGC3019452025-09-01
D765GC3019750X-Gut™ Chromic Gut SutureGC3019752025-09-01
D765GC3019P450X-Gut™ Chromic Gut SutureGC3019P452025-09-01
D765GC3019P750X-Gut™ Chromic Gut SutureGC3019P752025-09-01
D765GC4013P450X-Gut™ Chromic Gut SutureGC4013P452025-09-01
D765GC4019450X-Gut™ Chromic Gut SutureGC4019452025-09-01
D765GC4019750X-Gut™ Chromic Gut SutureGC4019752025-09-01
D765GC4019P450X-Gut™ Chromic Gut SutureGC4019P452025-09-01
D765GC5013P450X-Gut™ Chromic Gut SutureGC5013P452025-09-01
D765GC5016P450X-Gut™ Chromic Gut SutureGC5016P452025-09-01
D765GC5019450X-Gut™ Chromic Gut SutureGC5019452025-09-01
D765GP3019450X-Gut™ Plain Gut SutureGP3019452025-09-01
D765GP3019750X-Gut™ Plain Gut SutureGP3019752025-09-01
D765GP3022450X-Gut™ Plain Gut SutureGP3022452025-09-01
D765GP3024750X-Gut™ Plain Gut SutureGP3024752025-09-01
D765GP4019450X-Gut™ Plain Gut SutureGP4019452025-09-01
D765GP4019750X-Gut™ Plain Gut SutureGP4019752025-09-01
D765GC3019451X-Gut™ Chromic Gut SutureGC3019452025-09-01

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Primary DI, Brand, Company table
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