MECTALIF ANTERIOR IMPLANTS

GUDID 07630040727938

MectaLIF Anterior Stand-alone Screw Diam.5.5x35 Long Head (2x)

Medacta International SA

Spinal bone screw, non-bioabsorbable

• Primary Device ID: 07630040727938
• NIH Device Record Key: e6781d8a-e4e9-4b64-85b4-4079ec4b616f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MECTALIF ANTERIOR IMPLANTS
• Version Model Number: 03.30.153
• Company DUNS: 488227125
• Company Name: Medacta International SA
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07630040727938 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183426

FDA Product Code

• OVD: Intervertebral Fusion Device With Integrated Fixation, Lumbar

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-04-09
• Device Publish Date: 2019-03-20

On-Brand Devices [MECTALIF ANTERIOR IMPLANTS]

• 07630040727983: MectaLIF Anterior Stand-alone Screw Diam.5x40 Long Head (2x)
• 07630040727976: MectaLIF Anterior Stand-alone Screw Diam.5x35 Long Head (2x)
• 07630040727969: MectaLIF Anterior Stand-alone Screw Diam.5x30 Long Head (2x)
• 07630040727952: MectaLIF Anterior Stand-alone Screw Diam.5x25 Long Head (2x)
• 07630040727945: MectaLIF Anterior Stand-alone Screw Diam.5.5x40 Long Head (2x)
• 07630040727938: MectaLIF Anterior Stand-alone Screw Diam.5.5x35 Long Head (2x)
• 07630040727921: MectaLIF Anterior Stand-alone Screw Diam.5.5x30 Long Head (2x)
• 07630040727914: MectaLIF Anterior Stand-alone Screw Diam.5.5x25 Long Head (2x)
• 07630040727907: MectaLIF Anterior Stand-alone Screw Diam.5x40 Long Head
• 07630040727891: MectaLIF Anterior Stand-alone Screw Diam.5x35 Long Head
• 07630040727884: MectaLIF Anterior Stand-alone Screw Diam.5x30 Long Head
• 07630040727877: MectaLIF Anterior Stand-alone Screw Diam.5x25 Long Head
• 07630040727860: MectaLIF Anterior Stand-alone Screw Diam.5.5x40 Long Head
• 07630040727853: MectaLIF Anterior Stand-alone Screw Diam.5.5x35 Long Head
• 07630040727846: MectaLIF Anterior Stand-alone Screw Diam.5.5x30 Long Head
• 07630040727839: MectaLIF Anterior Stand-alone Screw Diam.5.5x25 Long Head