CREO

GUDID 00889095543650

CREO Fenestrated 9.5 x 70mm Modular Screw

GLOBUS MEDICAL, INC.

Trans-facet-screw internal spinal fixation system, sterile

• Primary Device ID: 00889095543650
• NIH Device Record Key: 0490f06a-3afb-4d50-81cb-fc769a0e0989
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CREO
• Version Model Number: 1192.1970
• 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	00889095543650 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172269

FDA Product Code

• NKB: Thoracolumbosacral pedicle screw system

Sterilization

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

[00889095543650]

Moist Heat or Steam Sterilization

[00889095543650]

Moist Heat or Steam Sterilization

[00889095543650]

Moist Heat or Steam Sterilization

[00889095543650]

Moist Heat or Steam Sterilization

[00889095543650]

Moist Heat or Steam Sterilization

[00889095543650]

Moist Heat or Steam Sterilization

[00889095543650]

Moist Heat or Steam Sterilization

[00889095543650]

Moist Heat or Steam Sterilization

[00889095543650]

Moist Heat or Steam Sterilization

[00889095543650]

Moist Heat or Steam Sterilization

[00889095543650]

Moist Heat or Steam Sterilization

[00889095543650]

Moist Heat or Steam Sterilization

[00889095543650]

Moist Heat or Steam Sterilization

[00889095543650]

Moist Heat or Steam Sterilization

[00889095543650]

Moist Heat or Steam Sterilization

[00889095543650]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-05-28
• Device Publish Date: 2021-05-20

On-Brand Devices [CREO]

• 00889095173406: Reduction Clip, Threaded, Long
• 00889095173291: Head Inserter, Threaded
• 00889095173208: Coronal Reducer
• 00889095733082: CREO 5.5 Locking Cap NS
• 00889095672107: Closed-Closed Lateral Connector, 5.5-6.35 to 6.5, 4 Set Screws, 9mm Wide, SS
• 00889095672022: Open-Closed Lateral Connector, 6.5 Open to 5.5-6.35 Closed, 3 Set Screws, 12mm Wide, SS
• 00889095671995: Open-Closed Lateral Connector, 6.5 Open to 5.5-6.35 Closed, 2 Set Screws, 12mm Wide, SS
• 00889095671841: Open-Open Lateral Connector, 5.5-6.35 to 6.5, 2 Set Screws, 12mm Wide, SS
• 00889095899269: CREO® Threaded Fenestrated Polyaxial Screw, 5.5 x 25
• 00889095856576: CREO Fenestrated, 5.0 x 60mm Polyaxial Screw, Threaded
• 00889095856569: CREO Fenestrated, 5.0 x 60mm Polyaxial Screw
• 00889095856552: CREO Fenestrated, 5.0 x 55mm Polyaxial Screw, Threaded
• 00889095856545: CREO Fenestrated, 5.0 x 55mm Polyaxial Screw
• 00889095856538: CREO Fenestrated, 5.0 x 50mm Polyaxial Screw, Threaded
• 00889095856521: CREO Fenestrated, 5.0 x 50mm Polyaxial Screw
• 00889095856439: CREO Fenestrated, 5.0 x 25mm Polyaxial Screw, Threaded
• 00889095856422: CREO Fenestrated, 5.0 x 25mm Polyaxial Screw
• 00889095856217: CREO Fenestrated, 4.5 x 60mm Polyaxial Screw, Threaded
• 00889095856200: CREO Fenestrated, 4.5 x 60mm Polyaxial Screw
• 00889095856194: CREO Fenestrated, 4.5 x 55mm Polyaxial Screw, Threaded
• 00889095856187: CREO Fenestrated, 4.5 x 55mm Polyaxial Screw
• 00889095856163: CREO Fenestrated, 4.5 x 50mm Polyaxial Screw
• 00889095856064: CREO Fenestrated, 4.5 x 25mm Polyaxial Screw
• 00889095851878: CREO DLX Reduction Screw Sleeve
• 00889095851861: CREO DLX Lateral Hook Holder
• 00889095851854: CREO DLX Reduction Screw Tab Remover
• 00889095845228: CREO DLX Quick Release Reduction Clip Pusher, Long
• 00889095845211: CREO DLX Quick Release Reduction Clip Pusher
• 00889095845204: CREO DLX Quick Release Reduction Clip, Long
• 00889095845198: CREO DLX Quick Release Reduction Clip
• 00889095815788: CREO DLX Offset Hook Holder
• 00889095815764: CREO DLX Hook Holder
• 00889095815740: CREO DLX Rigid Reduction Screwdriver Outer Sleeve
• 00889095815726: CREO DLX Rigid Reduction Screwdriver Shaft
• 00889095815719: CREO DLX Reduction Screw Counter Torque
• 00889095815702: CREO DLX Threaded Locking Cap Driver, Double Ended
• 00889095815689: CREO DLX Threaded Locking Cap Driver
• 00889095815603: CREO DLX Reduction Forceps
• 00889095815597: CREO DLX Reduction Fork
• 00889095815580: CREO DLX Pistol Grip Reducer
• 00889095815573: CREO DLX Overhead Reducer
• 00889095815542: CREO DLX Rigid Screwdriver Outer Sleeve, GPS
• 00889095815535: CREO DLX Rigid Screwdriver Shaft, GPS
• 00889095815511: CREO DLX Rigid Screwdriver Outer Sleeve
• 00889095815474: CREO DLX Rigid Screwdriver Shaft
• 00889095815467: CREO DLX External Head Positioner
• 00889095815450: CREO DLX Internal Head Positioner
• 00889095815436: CREO DLX Offset Connector Counter Torque
• 00889095815429: CREO DLX Counter Torque
• 00889095807424: CREO DLX Polyaxial Reduction Screw, 8.5x65mm