TOMOFIX 440895

GUDID H6794408950

TI TOMOFIX MEDIAL DISTAL FEMUR PLATE-4 HOLES/LEFT

SYNTHES (U.S.A.) LP

Orthopaedic fixation plate, non-bioabsorbable

• Primary Device ID: H6794408950
• NIH Device Record Key: 36fee9ea-f96a-4320-b83c-375e2c9ab521
• Commercial Distribution Discontinuation: 2018-10-12
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: TOMOFIX
• Version Model Number: 440.895
• Catalog Number: 440895
• Company DUNS: 832637081
• Company Name: SYNTHES (U.S.A.) LP
• 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)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	10886982220813 [Primary]
HIBCC	H6794408950 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081353

FDA Product Code

• HRS: PLATE, FIXATION, BONE

Sterilization

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

[H6794408950]

Moist Heat or Steam Sterilization

[H6794408950]

Moist Heat or Steam Sterilization

[H6794408950]

Moist Heat or Steam Sterilization

[H6794408950]

Moist Heat or Steam Sterilization

[H6794408950]

Moist Heat or Steam Sterilization

[H6794408950]

Moist Heat or Steam Sterilization

[H6794408950]

Moist Heat or Steam Sterilization

[H6794408950]

Moist Heat or Steam Sterilization

[H6794408950]

Moist Heat or Steam Sterilization

[H6794408950]

Moist Heat or Steam Sterilization

[H6794408950]

Moist Heat or Steam Sterilization

[H6794408950]

Moist Heat or Steam Sterilization

[H6794408950]

Moist Heat or Steam Sterilization

[H6794408950]

Moist Heat or Steam Sterilization

[H6794408950]

Moist Heat or Steam Sterilization

[H6794408950]

Moist Heat or Steam Sterilization

[H6794408950]

Moist Heat or Steam Sterilization

[H6794408950]

Moist Heat or Steam Sterilization

[H6794408950]

Moist Heat or Steam Sterilization

[H6794408950]

Moist Heat or Steam Sterilization

[H6794408950]

Moist Heat or Steam Sterilization

[H6794408950]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2023-09-18
• Device Publish Date: 2015-09-14

On-Brand Devices [TOMOFIX]

• 07611819254701: 2.0MM TOMOFIX(TM) GUIDE SLEEVE
• H679440895S0: TI TOMOFIX MEDIAL DISTAL FEMUR PL-4 HOLES/LT-STERILE
• H6794408950: TI TOMOFIX MEDIAL DISTAL FEMUR PLATE-4 HOLES/LEFT
• H679440885S0: TI TOMOFIX MEDIAL DISTAL FEMUR PL-4 HOLES/RT-STERILE
• H6794408850: TI TOMOFIX MEDIAL DISTAL FEMUR PLATE-4 HOLES/RIGHT