TRUFIX Bone Fixation System 45422303

GUDID 10614950005878

SELF DRILL BONE SCREWS 5/PKG 1.25MM SPLINE 3HD 2.3TD 9TL TI

ACE SURGICAL SUPPLY CO., INC.

Screw endosteal dental implant, one-piece

• Primary Device ID: 10614950005878
• NIH Device Record Key: 53eac852-4cc4-455d-9ec1-8870d63520c7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRUFIX Bone Fixation System
• Version Model Number: 45422303
• Catalog Number: 45422303
• Company DUNS: 042763706
• Company Name: ACE SURGICAL SUPPLY CO., INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(508)588-3100
• Email: ritaknight@acesurgical.com
• Phone: +1(508)588-3100
• Email: ritaknight@acesurgical.com

Device Dimensions

• Length: 9 Millimeter
• Length: 9 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00614950005871 [Primary]
GS1	10614950005878 [Package]; Contains: 00614950005871; Package: Plastic cassette [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K951392

FDA Product Code

• OAT: Implant, endosseous, orthodontic

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[10614950005878]

Radiation Sterilization

[10614950005878]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-12-28

On-Brand Devices [TRUFIX Bone Fixation System]

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