Ti6 Internal Fixation System TS4012

GUDID 00885556836767

TI6 TITANIUM SOLID 4.0MM X 12MM BONE SCREW

Smith & Nephew, Inc.

Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: 00885556836767
• NIH Device Record Key: 490343f6-9fb6-4667-8e0c-a572cd767a6f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ti6 Internal Fixation System
• Version Model Number: TS4012
• Catalog Number: TS4012
• Company DUNS: 109903521
• Company Name: Smith & Nephew, Inc.
• Device Count: 1
• DM Exempt: false
• 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(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885556836767 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060026

FDA Product Code

• HWC: Screw, fixation, bone

Sterilization

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

[00885556836767]

Moist Heat or Steam Sterilization

[00885556836767]

Moist Heat or Steam Sterilization

[00885556836767]

Moist Heat or Steam Sterilization

[00885556836767]

Moist Heat or Steam Sterilization

[00885556836767]

Moist Heat or Steam Sterilization

[00885556836767]

Moist Heat or Steam Sterilization

[00885556836767]

Moist Heat or Steam Sterilization

[00885556836767]

Moist Heat or Steam Sterilization

[00885556836767]

Moist Heat or Steam Sterilization

[00885556836767]

Moist Heat or Steam Sterilization

[00885556836767]

Moist Heat or Steam Sterilization

[00885556836767]

Moist Heat or Steam Sterilization

[00885556836767]

Moist Heat or Steam Sterilization

[00885556836767]

Moist Heat or Steam Sterilization

[00885556836767]

Moist Heat or Steam Sterilization

[00885556836767]

Moist Heat or Steam Sterilization

[00885556836767]

Moist Heat or Steam Sterilization

[00885556836767]

Moist Heat or Steam Sterilization

[00885556836767]

Moist Heat or Steam Sterilization

[00885556836767]

Moist Heat or Steam Sterilization

[00885556836767]

Moist Heat or Steam Sterilization

[00885556836767]

Moist Heat or Steam Sterilization

[00885556836767]

Moist Heat or Steam Sterilization

[00885556836767]

Moist Heat or Steam Sterilization

[00885556836767]

Moist Heat or Steam Sterilization

[00885556836767]

Moist Heat or Steam Sterilization

[00885556836767]

Moist Heat or Steam Sterilization

[00885556836767]

Moist Heat or Steam Sterilization

[00885556836767]

Moist Heat or Steam Sterilization

[00885556836767]

Moist Heat or Steam Sterilization

[00885556836767]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-07-25
• Device Publish Date: 2022-12-22

On-Brand Devices [Ti6 Internal Fixation System]

• 00885556835227: BONE REDUCTION FORCEPS SERRATED
• 00885556835210: BONE REDUCTION FORCEPS SWEETHEART STYLE
• 00885556835500: TQSERIES QUICKSNAP 3PRONG DRIVER SHAFT
• 00885556835494: THSERIES REMOVAL DRIVER SHAFT
• 00885556835470: THSERIES CANN. DEPTH GAUGE
• 00885556835463: THSERIES CANN. DRIVER SHAFT
• 00885556835432: TCSERIES CANN. DEPTH GAUGE/CSINK. 3.0/4.0MM SCREWS
• 00885556835425: TCSERIES CANN. DEPTH GAUGE/CSINK. 2.0/2.5MM SCREWS
• 00885556835418: TCSERIES 3.0 / 4.0MM CANNULATED DRIVER SHAFT
• 00885556835401: TCSERIES 2.0 / 2.5MM CANNULATED DRIVER SHAFT
• 00885556835395: TS-SERIES COUNTERSINK FOR 3.0 & 4.0MM SCREWS - AO
• 00885556835388: TS-SERIES COUNTERSINK FOR 3.0 & 4.0MM SCREWS
• 00885556835371: TS-SERIES COUNTERSINK FOR 2.0 & 2.5MM SCREWS - AO
• 00885556835364: TS-SERIES COUNTERSINK FOR 2.0 & 2.5MM SCREWS
• 00885556835357: TSSERIES DRILL GUIDE FOR 3.0 & 4.0MM SCREWS
• 00885556835340: TSSERIES DRILL GUIDE FOR 2.0 & 2.5MM SCREWS
• 00885556835319: TSSERIES 3.0 / 4.0MM DRIVER SHAFT
• 00885556835302: TSSERIES 2.0 / 2.5MM DRIVER SHAFT
• 00885556835258: SCREW REMOVAL TOOL
• 00885556835241: SCREW PICKUP FORCEPS
• 00885556835234: BONE REDUCTION FORCEPS SCARF
• 00885556835197: TITANIUM SWIVEL DRIVER HANDLE
• 00885556835180: TI6 DIGITAL FUSION DRIVER SHAFT
• 00885556835036: TI6 DIGITAL SCREW COUNTERSINKDEPTH GAUGE
• 00885556836156: TI6 HEADLESS 2.5MM X 22MM BONE SCREW
• 00885556836149: TI6 HEADLESS 2.5MM X 20MM BONE SCREW
• 00885556836132: TI6 HEADLESS 2.5MM X 18MM BONE SCREW
• 00885556836125: TI6 HEADLESS 2.5MM X 16MM BONE SCREW
• 00885556836118: TI6 HEADLESS 2.5MM X 14MM BONE SCREW
• 00885556836101: TI6 HEADLESS 2.5MM X 12MM BONE SCREW
• 00885556836095: TI6 HEADLESS 2.5MM X 10MM BONE SCREW
• 00885556836088: TI6 LOW PROFILE 4.0MM X 50MM BONE SCREW
• 00885556836071: TI6 LOW PROFILE 4.0MM X 46MM BONE SCREW
• 00885556836064: TI6 LOW PROFILE 4.0MM X 42MM BONE SCREW
• 00885556836057: TI6 LOW PROFILE 4.0MM X 40MM BONE SCREW
• 00885556836040: TI6 LOW PROFILE 4.0MM X 38MM BONE SCREW
• 00885556836033: TI6 LOW PROFILE 4.0MM X 36MM BONE SCREW
• 00885556836026: TI6 LOW PROFILE 4.0MM X 34MM BONE SCREW
• 00885556836019: TI6 LOW PROFILE 4.0MM X 32MM BONE SCREW
• 00885556836002: TI6 LOW PROFILE 4.0MM X 30MM BONE SCREW
• 00885556835999: TI6 LOW PROFILE 4.0MM X 28MM BONE SCREW
• 00885556835982: TI6 LOW PROFILE 4.0MM X 26MM BONE SCREW
• 00885556835975: TI6 LOW PROFILE 4.0MM X 24MM BONE SCREW
• 00885556835968: TI6 LOW PROFILE 4.0MM X 22MM BONE SCREW
• 00885556835951: TI6 LOW PROFILE 4.0MM X 20MM BONE SCREW
• 00885556835944: TI6 LOW PROFILE 4.0MM X 18MM BONE SCREW
• 00885556835937: TI6 LOW PROFILE 4.0MM X 16MM BONE SCREW
• 00885556835913: TI6 LOW PROFILE 4.0MM X 12MM BONE SCREW
• 00885556835890: TI6 LOW PROFILE 3.0MM X 36MM BONE SCREW
• 00885556835883: TI6 LOW PROFILE 3.0MM X 34MM BONE SCREW