TRUFIX Bone Fixation System 45426502

GUDID 00614950005970

DRILL POINT TENTING SCREW 4HD 2.3TD 11TL (6AL4VELI) NON STERILE

ACE SURGICAL SUPPLY CO., INC.

Orthodontic anchoring screw
Primary Device ID00614950005970
NIH Device Record Key21d3e8c2-c773-4175-a599-abd76a88c8fc
Commercial Distribution StatusIn Commercial Distribution
Brand NameTRUFIX Bone Fixation System
Version Model Number45426502
Catalog Number45426502
Company DUNS042763706
Company NameACE SURGICAL SUPPLY CO., INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(508)588-3100
Emailritaknight@acesurgical.com
Phone+1(508)588-3100
Emailritaknight@acesurgical.com
Phone+1(508)588-3100
Emailritaknight@acesurgical.com
Phone+1(508)588-3100
Emailritaknight@acesurgical.com
Phone+1(508)588-3100
Emailritaknight@acesurgical.com
Phone+1(508)588-3100
Emailritaknight@acesurgical.com
Phone+1(508)588-3100
Emailritaknight@acesurgical.com
Phone+1(508)588-3100
Emailritaknight@acesurgical.com
Phone+1(508)588-3100
Emailritaknight@acesurgical.com
Phone+1(508)588-3100
Emailritaknight@acesurgical.com
Phone+1(508)588-3100
Emailritaknight@acesurgical.com
Phone+1(508)588-3100
Emailritaknight@acesurgical.com
Phone+1(508)588-3100
Emailritaknight@acesurgical.com
Phone+1(508)588-3100
Emailritaknight@acesurgical.com
Phone+1(508)588-3100
Emailritaknight@acesurgical.com
Phone+1(508)588-3100
Emailritaknight@acesurgical.com
Phone+1(508)588-3100
Emailritaknight@acesurgical.com

Device Dimensions

Length11 Millimeter
Length11 Millimeter
Length11 Millimeter
Length11 Millimeter
Length11 Millimeter
Length11 Millimeter
Length11 Millimeter
Length11 Millimeter
Length11 Millimeter
Length11 Millimeter
Length11 Millimeter
Length11 Millimeter
Length11 Millimeter
Length11 Millimeter
Length11 Millimeter
Length11 Millimeter
Length11 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100614950005970 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OATImplant, endosseous, orthodontic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00614950005970]

Radiation Sterilization

[00614950005970]

Radiation Sterilization

[00614950005970]

Radiation Sterilization

[00614950005970]

Radiation Sterilization

[00614950005970]

Radiation Sterilization

[00614950005970]

Radiation Sterilization

[00614950005970]

Radiation Sterilization

[00614950005970]

Radiation Sterilization

[00614950005970]

Radiation Sterilization

[00614950005970]

Radiation Sterilization

[00614950005970]

Radiation Sterilization

[00614950005970]

Radiation Sterilization

[00614950005970]

Radiation Sterilization

[00614950005970]

Radiation Sterilization

[00614950005970]

Radiation Sterilization

[00614950005970]

Radiation Sterilization

[00614950005970]

Radiation Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-12-28

On-Brand Devices [TRUFIX Bone Fixation System]

10614950007070truTACK 2.5HD 5TL 10/PK THREADED HX TI STERILE (6AL4VELI)
10614950007063truTACK 2.5HD 3TL 10/PK THREADED HX TI STERILE (6AL4VELI)
10614950006585ACE ORTHO BONE SCREW 1.8X10MM CUFF STERILE TI 5/PKG TI (6AL4V ELI)
10614950006578ACE ORTHO BONE SCREW 1.8X8MM CUFF STERILE TI 5/PKG TI (6AL4V ELI)
10614950006561ACE ORTHO BONE SCREW 1.8X6MM CUFF STERILE TI 5/PKG TI (6AL4V ELI)
10614950006554ACE ORTHO BONE SCREW 1.8X10MM STERILE TI (6AL4V ELI) 5/PKG
10614950006547ACE ORTHO BONE SCREW 1.8X8MM STERILE TI (6AL4V ELI) 5/PKG
10614950006530ACE ORTHO BONE SCREW 1.8X6MM STERILE TI (6AL4V ELI) 5/PKG
00614950006526ORTHO BONE SCREW 1.8X10MM CUFF STERILE TI 6AL4VELI
00614950006519ACE ORTHO BONE SCREW 1.8X8MM CUFF STERILE TI (6AL4V ELI)
00614950006502ACE ORTHO BONE SCREW 1.8X6MM CUFF STERILE TI (6AL4VELI)
00614950006496ACE ORTHO BONE SCREW 1.8X10MM STERILE TI (6AL-4V ELI)
00614950006489ACE ORTHO BONE SCREW 1.8X8MM STERILE TI (6AL-4V ELI)
00614950006472ACE ORTHO BONE SCREW 1.8X6MM STERILE TI (6AL-4V ELI)
00614950006465ORTHODONTIC 1.5/1.8 X 10MM BONE SCREW TACK TIP STERILE TI 6AL-4V ELI
00614950006458ORTHODONTIC 1.5/1.8 X 8MM BONE SCREW TACK TIP STERILE TI 6AL 4V ELI
10614950006448ACE ORTHO BONE SCREW 1.5X10MM CUFF STERILE TI(6AL4VELI)5/PKG
10614950006431ACE ORTHO BONE SCREW 1.5X8MM CUFF STERILE TI(6AL4VELI)5/PKG
10614950006424ACE ORTHO BONE SCREW 1.5X6 CUFF STERILE TI(6AL4VELI)5/PKG
10614950006417ACE ORTHO BONE SCREW 1.5X10MM STERILE TI (6AL4VELI) 5/PKG
10614950006400ACE ORTHO BONE SCREW 1.5X8MM STERILE TI (6AL4VELI) 5/PKG
10614950006394ACE ORTHO BONE SCREW 1.5X6MM STERILE TI (6AL4VELI) 5/PKG
00614950006380ACE ORTHO BONE SCREW 1.5X10MM W/CUFF STERILE TI (6AL4V ELI)
00614950006373ACE ORTHO BONE SCREW 1.5X8MM W/CUFF STERILE TI (6AL4V ELI)
00614950006366ACE ORTHO BONE SCREW 1.5X6MM W/CUFF STERILE TI (6AL4V ELI)
00614950006359ACE ORTHO BONE SCREW 1.5X10MM STERILE TI (6AL-4V ELI)
00614950006342ACE ORTHO BONE SCREW 1.5X8MM STERILE TI (6AL-4V ELI)
00614950006335ACE ORTHO BONE SCREW 1.5X6MM STERILE TI (6AL-4V ELI)
00614950006328SURGICAL BONE PLATE Y SHAPE 6-HOLE 18MM LONG .5MM THICK
00614950006311SURGICAL BONE PLATE T SHAPE 7-HOLE .5MM THICK 19MM TL
00614950006304SURGICAL BONE PLATE 2 HOLE .5MM THICK 7MM LONG
00614950006298SURGICAL BONE PLATE MICRO 8-HOLE .5MM THICK 31MM LONG MODIFIED 2009
00614950006281SURGICAL BONE PLATE MICRO 4-HOLE .5MM THICK 15MM LONG
00614950006274DRILL POINT TENTING SCREW 4HD 1.5TD 15TL (6AL4VELI) NON STERILE
00614950006267DRILL POINT TENTING SCREW 4HD 1.5TD 11TL (6AL4VELI) NON STERILE
00614950006250DRILL POINT TENTING SCREW 4HD 1.5TD 7TL (6AL4VELI) NON STERILE
10614950006240truSCREW 3HD 2.0 X 15MM 5/PKG 1.25MM SPLINE TI STERILE (6AL4VELI)
10614950006233truSCREW 3HD 2.0X 13.5MM 5/PKG 1.25MM SPLINE TI STERILE (6AL4VELI)
10614950006226truSCREW 3HD 2.0 X 12MM 5/PKG 1.25MM SPLINE TI STERILE (6AL4VELI)
10614950006219truSCREW 3HD 2.0 X 10.5MM 5/PK 1.25MM SPLINE TI STERILE (6AL4VELI)
10614950006202truSCREW 3HD 2.0 X 9MM 5/PKG 1.25MM SPLINE TI STERILE (6AL4VELI)
10614950006196truSCREW 3HD 2.0 X 7.5MM 5/PKG 1.25MM SPLINE TI STERILE (6AL4VELI)
10614950006189truSCREW 3HD 2.0 X 6MM 5/PKG 1.25MM SPLINE TI STERILE (6AL4VELI)
00614950006175* SURGICAL BONE PLATE 8-HOLES .6MM THICK ORBITAL SHAPE 43TL
10614950006165truSCREW 3HD 1.5 X 15MM 5/PKG 1.25MM SPLINE TI STERILE (6AL4VELI)
10614950006158truSCREW 3HD 1.5 X 13.5MM 5/PK 1.25MM SPLINE TI STERILE (6AL4VELI)
10614950006141truSCREW 3HD 1.5 X 12MM 5/PKG 1.25MM SPLINE TI (6AL4VELI)
10614950006134truSCREW 3HD 1.5 X 10.5MM 5/PK 1.25MM SPLINE TI STERILE (6AL4VELI)
10614950006127truSCREW 3HD 1.5 X 9MM 5/PKG 1.25MM SPLINE TI STERILE (6AL4VELI)
10614950006110truSCREW 3HD 1.5 X 7.5MM 5/PK 1.25MM SPLINE TI STERILE (6AL4VELI)
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