ACDF Stand Alone Cervical

GUDID 07630040726900

Mecta-C SA Tap Screw Lag Ø3.8x14 (1x)

Medacta International SA

Metallic spinal interbody fusion cage

• Primary Device ID: 07630040726900
• NIH Device Record Key: e9d02f65-82ec-46fd-8b7c-fd658567c402
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACDF Stand Alone Cervical
• Version Model Number: 03.18.712
• 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	07630040726900 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192906

FDA Product Code

• OVE: Intervertebral Fusion Device With Integrated Fixation, Cervical

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-07-06
• Device Publish Date: 2020-06-26

On-Brand Devices [ACDF Stand Alone Cervical]

• 07630040726368: Mecta-C SA – Plate Hybrid Lag h10
• 07630040726351: Mecta-C SA – Plate Hybrid Lag h9
• 07630040726344: Mecta-C SA – Plate Hybrid Lag h8
• 07630040726337: Mecta-C SA – Plate Hybrid Lag h7
• 07630040726320: Mecta-C SA – Plate Hybrid Lag h6
• 07630040724739: Mecta-C SA PEEK Cage 15x13x5x7°
• 07630040725729: Mecta-C SA TiPEEK Cage 18x15x6x7°
• 07630040725712: Mecta-C SA TiPEEK Cage 18x15x5x7°
• 07630040725705: Mecta-C SA TiPEEK Cage 16x14x12x7°
• 07630040725699: Mecta-C SA TiPEEK Cage 16x14x11x7°
• 07630040725682: Mecta-C SA TiPEEK Cage 16x14x10x7°
• 07630040725675: Mecta-C SA TiPEEK Cage 16x14x9x7°
• 07630040725668: Mecta-C SA TiPEEK Cage 16x14x8x7°
• 07630040725651: Mecta-C SA TiPEEK Cage 16x14x7x7°
• 07630040725644: Mecta-C SA TiPEEK Cage 16x14x6x7°
• 07630040725637: Mecta-C SA TiPEEK Cage 16x14x5x7°
• 07630040725620: Mecta-C SA TiPEEK Cage 15x13x12x7°
• 07630040725613: Mecta-C SA TiPEEK Cage 15x13x11x7°
• 07630040725606: Mecta-C SA TiPEEK Cage 15x13x10x7°
• 07630040725590: Mecta-C SA TiPEEK Cage 15x13x9x7°
• 07630040725583: Mecta-C SA TiPEEK Cage 15x13x8x7°
• 07630040725576: Mecta-C SA TiPEEK Cage 15x13x7x7°
• 07630040725569: Mecta-C SA TiPEEK Cage 15x13x6x7°
• 07630040725552: Mecta-C SA TiPEEK Cage 15x13x5x7°
• 07630040725545: Mecta-C SA PEEK Cage 18x15x12x7°
• 07630040725538: Mecta-C SA PEEK Cage 18x15x11x7°
• 07630971240803: Mecta-C SA Antibackout Trio h9-h12
• 07630971240797: Mecta-C SA Antibackout Trio h7-h8
• 07630971238282: Mecta-C SA Antibackout Hybrid
• 07630971238275: Mecta-C SA Antibackout Quattro h9-h12
• 07630971238268: Mecta-C SA Antibackout Quattro h5-h8
• 07630971238251: Mecta-C SA Antibackout Trio h5-h6
• 07630971238244: Mecta-C SA Antibackout Flush h9-h12
• 07630971238237: Mecta-C SA Antibackout Flush h6-h8
• 07630040732390: Mecta-C SA Tap Screw Lag Ø4.2x22 (2x)
• 07630040732383: Mecta-C SA Tap Screw Lag Ø3.8x22 (2x)
• 07630040732376: Mecta-C SA Tap Screw Lock Ø4.2x22 (2x)
• 07630040732369: Mecta-C SA Tap Screw Lock Ø3.8x22 (2x)
• 07630040732352: Mecta-C SA Tap Screw Lag Ø4.2x22 (1x)
• 07630040732345: Mecta-C SA Tap Screw Lag Ø3.8x22 (1x)
• 07630040732338: Mecta-C SA Tap Screw Lock Ø4.2x22 (1x)
• 07630040732321: Mecta-C SA Tap Screw Lock Ø3.8x22 (1x)
• 07630040727181: Mecta-C SA Tap Screw Lag Ø4.2x20 (2x)
• 07630040727174: Mecta-C SA Tap Screw Lag Ø4.2x18 (2x)
• 07630040727167: Mecta-C SA Tap Screw Lag Ø4.2x16 (2x)
• 07630040727150: Mecta-C SA Tap Screw Lag Ø4.2x14 (2x)
• 07630040727143: Mecta-C SA Tap Screw Lag Ø4.2x12 (2x)
• 07630040727136: Mecta-C SA Tap Screw Lag Ø3.8x20 (2x)
• 07630040727129: Mecta-C SA Tap Screw Lag Ø3.8x18 (2x)
• 07630040727112: Mecta-C SA Tap Screw Lag Ø3.8x16 (2x)