ADIRA

GUDID 00193982535889

ADIRA Plate, 2-Hole, 19mm, RLX

GLOBUS MEDICAL, INC.

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 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: 00193982535889
• NIH Device Record Key: a2c275b3-da18-458f-a1b4-7ff774eb8469
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ADIRA
• Version Model Number: 1264.2119
• Company DUNS: 139105691
• Company Name: GLOBUS MEDICAL, INC.
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00193982535889 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233735

FDA Product Code

• OVD: Intervertebral fusion device with integrated fixation, lumbar

Sterilization

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

[00193982535889]

Moist Heat or Steam Sterilization

[00193982535889]

Moist Heat or Steam Sterilization

[00193982535889]

Moist Heat or Steam Sterilization

[00193982535889]

Moist Heat or Steam Sterilization

[00193982535889]

Moist Heat or Steam Sterilization

[00193982535889]

Moist Heat or Steam Sterilization

[00193982535889]

Moist Heat or Steam Sterilization

[00193982535889]

Moist Heat or Steam Sterilization

[00193982535889]

Moist Heat or Steam Sterilization

[00193982535889]

Moist Heat or Steam Sterilization

[00193982535889]

Moist Heat or Steam Sterilization

[00193982535889]

Moist Heat or Steam Sterilization

[00193982535889]

Moist Heat or Steam Sterilization

[00193982535889]

Moist Heat or Steam Sterilization

[00193982535889]

Moist Heat or Steam Sterilization

[00193982535889]

Moist Heat or Steam Sterilization

[00193982535889]

Moist Heat or Steam Sterilization

[00193982535889]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-04-09
• Device Publish Date: 2024-04-01

On-Brand Devices [ADIRA]

• 00193982535902: ADIRA Plate, 2-Hole, 23mm, RLX
• 00193982535896: ADIRA Plate, 2-Hole, 21mm, RLX
• 00193982535889: ADIRA Plate, 2-Hole, 19mm, RLX
• 00193982535872: ADIRA Plate, 2-Hole, 17mm, RLX
• 00193982535865: ADIRA Plate, 2-Hole, 15mm, RLX
• 00193982535841: ADIRA Plate, 2-Hole, 23mm, Static
• 00193982535834: ADIRA Plate, 2-Hole, 21mm, Static
• 00193982535827: ADIRA Plate, 2-Hole, 19mm, Static
• 00193982535810: ADIRA Plate, 2-Hole, 17mm, Static
• 00193982535803: ADIRA Plate, 2-Hole, 15mm, Static
• 00193982535797: ADIRA Plate, 1-Hole, 11.5mm, Up, RLX
• 00193982535780: ADIRA Plate, 1-Hole, 10.5mm, Up, RLX
• 00193982535773: ADIRA Plate, 1-Hole, 9.5mm, Up, RLX
• 00193982535766: ADIRA Plate, 1-Hole, 8.5mm, Up, RLX
• 00193982535759: ADIRA Plate, 1-Hole, 7.5mm, Up, RLX
• 00193982535742: ADIRA Plate, 1-Hole, 11.5mm, Static
• 00193982535735: ADIRA Plate, 1-Hole, 10.5mm, Static
• 00193982535728: ADIRA Plate, 1-Hole, 9.5mm, Static
• 00193982535711: ADIRA Plate, 1-Hole, 8.5mm, Static
• 00193982535704: ADIRA Plate, 1-Hole, 7.5mm, Static
• 00193982535698: ADIRA Alignment Screw, M4.5, Green
• 00193982535681: ADIRA Alignment Screw, M4, Blue
• 00193982535674: Torque-Limiting Quick Connect Handle, 1.0Nm
• 00193982535667: ADIRA Threaded Plate Holder
• 00193982535650: Blocking Screw Driver, 2.5mm
• 00193982535643: ADIRA Plate Inserter, Sleeve
• 00193982535636: ADIRA Plate Inserter, Threaded Shaft