TRUFIX Bone Fixation System 45491711

GUDID 10614950006530

ACE ORTHO BONE SCREW 1.8X6MM STERILE TI (6AL4V ELI) 5/PKG

ACE SURGICAL SUPPLY CO., INC.

Orthodontic anchoring screw Orthodontic anchoring screw Orthodontic anchoring screw Orthodontic anchoring screw Orthodontic anchoring screw Orthodontic anchoring screw Orthodontic anchoring screw Orthodontic anchoring screw Orthodontic anchoring screw Orthodontic anchoring screw Orthodontic anchoring screw Orthodontic anchoring screw Orthodontic anchoring screw Orthodontic anchoring screw Orthodontic anchoring screw Orthodontic anchoring screw Orthodontic anchoring screw

• Primary Device ID: 10614950006530
• NIH Device Record Key: 252f39a1-3039-46d5-a6ed-4d4dd26a2ac9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRUFIX Bone Fixation System
• Version Model Number: 45491711
• Catalog Number: 45491711
• 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: true
• 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
• Phone: +1(508)588-3100
• Email: ritaknight@acesurgical.com
• Phone: +1(508)588-3100
• Email: ritaknight@acesurgical.com
• Phone: +1(508)588-3100
• Email: ritaknight@acesurgical.com
• Phone: +1(508)588-3100
• Email: ritaknight@acesurgical.com
• Phone: +1(508)588-3100
• Email: ritaknight@acesurgical.com
• Phone: +1(508)588-3100
• Email: ritaknight@acesurgical.com
• Phone: +1(508)588-3100
• Email: ritaknight@acesurgical.com
• Phone: +1(508)588-3100
• Email: ritaknight@acesurgical.com
• Phone: +1(508)588-3100
• Email: ritaknight@acesurgical.com
• Phone: +1(508)588-3100
• Email: ritaknight@acesurgical.com
• Phone: +1(508)588-3100
• Email: ritaknight@acesurgical.com
• Phone: +1(508)588-3100
• Email: ritaknight@acesurgical.com
• Phone: +1(508)588-3100
• Email: ritaknight@acesurgical.com
• Phone: +1(508)588-3100
• Email: ritaknight@acesurgical.com
• Phone: +1(508)588-3100
• Email: ritaknight@acesurgical.com

Device Dimensions

• Length: 6 Millimeter
• Length: 6 Millimeter
• Length: 6 Millimeter
• Length: 6 Millimeter
• Length: 6 Millimeter
• Length: 6 Millimeter
• Length: 6 Millimeter
• Length: 6 Millimeter
• Length: 6 Millimeter
• Length: 6 Millimeter
• Length: 6 Millimeter
• Length: 6 Millimeter
• Length: 6 Millimeter
• Length: 6 Millimeter
• Length: 6 Millimeter
• Length: 6 Millimeter
• Length: 6 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00614950006533 [Primary]
GS1	10614950006530 [Package]; Contains: 00614950006533; Package: Tyvec Bag [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061397

FDA Product Code

• OAT: Implant, endosseous, orthodontic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-24

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)