TSLP 489497

GUDID H9814894970

TI THORACOLUMBAR SPINE LOCKING PLATE 97MM

Synthes GmbH

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: H9814894970
• NIH Device Record Key: 6065d096-ec50-4138-ba68-966d72763842
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TSLP
• Version Model Number: 489.497
• Catalog Number: 489497
• Company DUNS: 486711679
• Company Name: Synthes GmbH
• 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
• 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	10705034784670 [Primary]
HIBCC	H9814894970 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K020244

FDA Product Code

• KWQ: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Sterilization

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

[H9814894970]

Moist Heat or Steam Sterilization

[H9814894970]

Moist Heat or Steam Sterilization

[H9814894970]

Moist Heat or Steam Sterilization

[H9814894970]

Moist Heat or Steam Sterilization

[H9814894970]

Moist Heat or Steam Sterilization

[H9814894970]

Moist Heat or Steam Sterilization

[H9814894970]

Moist Heat or Steam Sterilization

[H9814894970]

Moist Heat or Steam Sterilization

[H9814894970]

Moist Heat or Steam Sterilization

[H9814894970]

Moist Heat or Steam Sterilization

[H9814894970]

Moist Heat or Steam Sterilization

[H9814894970]

Moist Heat or Steam Sterilization

[H9814894970]

Moist Heat or Steam Sterilization

[H9814894970]

Moist Heat or Steam Sterilization

[H9814894970]

Moist Heat or Steam Sterilization

[H9814894970]

Moist Heat or Steam Sterilization

[H9814894970]

Moist Heat or Steam Sterilization

[H9814894970]

Moist Heat or Steam Sterilization

[H9814894970]

Moist Heat or Steam Sterilization

[H9814894970]

Moist Heat or Steam Sterilization

[H9814894970]

Moist Heat or Steam Sterilization

[H9814894970]

Moist Heat or Steam Sterilization

[H9814894970]

Moist Heat or Steam Sterilization

[H9814894970]

Moist Heat or Steam Sterilization

[H9814894970]

Moist Heat or Steam Sterilization

[H9814894970]

Moist Heat or Steam Sterilization

[H9814894970]

Moist Heat or Steam Sterilization

[H9814894970]

Moist Heat or Steam Sterilization

[H9814894970]

Moist Heat or Steam Sterilization

[H9814894970]

Moist Heat or Steam Sterilization

[H9814894970]

Moist Heat or Steam Sterilization

[H9814894970]

Moist Heat or Steam Sterilization

[H9814894970]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-04-27
• Device Publish Date: 2015-09-14

On-Brand Devices [TSLP]

• H9814895120: TI THORACOLUMBAR SPINE LOCKING PLATE 109MM
• H9814895100: TI THORACOLUMBAR SPINE LOCKING PLATE 106MM
• H9814895060: TI THORACOLUMBAR SPINE LOCKING PLATE 103MM
• H9814895000: TI THORACOLUMBAR SPINE LOCKING PLATE 100MM
• H9814894970: TI THORACOLUMBAR SPINE LOCKING PLATE 97MM
• H9814894930: TI THORACOLUMBAR SPINE LOCKING PLATE 94MM
• H9814894900: TI THORACOLUMBAR SPINE LOCKING PLATE 91MM
• H9814894890: TI THORACOLUMBAR SPINE LOCKING PLATE 88MM
• H9814894870: TI THORACOLUMBAR SPINE LOCKING PLATE 85MM
• H9814894830: TI THORACOLUMBAR SPINE LOCKING PLATE 82MM
• H9814894800: TI THORACOLUMBAR SPINE LOCKING PLATE 79MM
• H9814894750: TI THORACOLUMBAR SPINE LOCKING PLATE 76MM
• H9814894740: TI THORACOLUMBAR SPINE LOCKING PLATE 73MM
• H9814894700: TI THORACOLUMBAR SPINE LOCKING PLATE 70MM
• H9814894660: TI THORACOLUMBAR SPINE LOCKING PLATE 67MM
• H9814894630: TI THORACOLUMBAR SPINE LOCKING PLATE 64MM
• H9814894610: TI THORACOLUMBAR SPINE LOCKING PLATE 61MM
• H9814894580: TI THORACOLUMBAR SPINE LOCKING PLATE 58MM
• H9814894560: TI THORACOLUMBAR SPINE LOCKING PLATE 55MM
• H9814894530: TI THORACOLUMBAR SPINE LOCKING PLATE 52MM
• H9814894500: TI THORACOLUMBAR SPINE LOCKING PLATE 49MM
• H9814894460: TI THORACOLUMBAR SPINE LOCKING PLATE 46MM
• H9814894430: TI THORACOLUMBAR SPINE LOCKING PLATE 43MM
• H9814894400: TI THORACOLUMBAR SPINE LOCKING PLATE 40MM