3250525

GUDID 10705034005362

ALC DYNAMIZED FIXATION SYSTEM TRANSVERSE FIXATOR PLATE 25mm

DEPUY SPINE, LLC

Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 10705034005362
• NIH Device Record Key: 6ea4749d-2b25-4983-9a0f-ca551ae21946
• Commercial Distribution Discontinuation: 2018-07-31
• Commercial Distribution Status: Not in Commercial Distribution
• Version Model Number: 3250525
• Catalog Number: 3250525
• Company DUNS: 107105876
• Company Name: DEPUY SPINE, LLC
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10705034005362 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K953978

FDA Product Code

• KWQ: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Sterilization

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

[10705034005362]

Moist Heat or Steam Sterilization

[10705034005362]

Moist Heat or Steam Sterilization

[10705034005362]

Moist Heat or Steam Sterilization

[10705034005362]

Moist Heat or Steam Sterilization

[10705034005362]

Moist Heat or Steam Sterilization

[10705034005362]

Moist Heat or Steam Sterilization

[10705034005362]

Moist Heat or Steam Sterilization

[10705034005362]

Moist Heat or Steam Sterilization

[10705034005362]

Moist Heat or Steam Sterilization

[10705034005362]

Moist Heat or Steam Sterilization

[10705034005362]

Moist Heat or Steam Sterilization

[10705034005362]

Moist Heat or Steam Sterilization

[10705034005362]

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: 2015-09-24

Devices Manufactured by DEPUY SPINE, LLC

• 10705034003252 - ISOLA: 2024-04-05 ISOLA SPINE SYSTEM SPINAL WIRE WITH BUTTON 177.8mm
• 10705034003269 - ISOLA: 2024-04-03 ISOLA SPINE SYSTEM DOUBLE WIRE 304.8mm
• 10705034003276 - ISOLA: 2024-04-03 ISOLA SPINE SYSTEM BEADED WIRE 304.8mm
• 10705034202952 - EXPEDIUM: 2024-04-03 EXPEDIUM SPINE SYSTEM WIRE CUTTER
• 10705034302300 - EXPEDIUM: 2024-04-03 EXPEDIUM SPINE SYSTEM SMALL WIRE CUTTER
• 10705034314716 - NA: 2024-04-03 MODIFIED INSTRUMENT ILIAC CUTTER ASSEMBLY 7.25mm
• 10705034484044 - NA: 2024-04-03 MODIFIED INSTRUMENT TREPHINE
• 10705034492353 - NA: 2024-04-03 MODIFIED INSTRUMENT BONE HARVESTER