CORBEL

GUDID 00193982194000

CORBEL SPACER, 29 x 39, 21mm, 8°

GLOBUS MEDICAL, INC.

Metallic spinal interbody fusion cage

• Primary Device ID: 00193982194000
• NIH Device Record Key: e3a6ae76-dfc7-4b00-809e-d68836be9a9e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CORBEL
• Version Model Number: 1198.1121
• 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	00193982194000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201087

FDA Product Code

• OVD: Intervertebral fusion device with integrated fixation, lumbar

Sterilization

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

[00193982194000]

Moist Heat or Steam Sterilization

[00193982194000]

Moist Heat or Steam Sterilization

[00193982194000]

Moist Heat or Steam Sterilization

[00193982194000]

Moist Heat or Steam Sterilization

[00193982194000]

Moist Heat or Steam Sterilization

[00193982194000]

Moist Heat or Steam Sterilization

[00193982194000]

Moist Heat or Steam Sterilization

[00193982194000]

Moist Heat or Steam Sterilization

[00193982194000]

Moist Heat or Steam Sterilization

[00193982194000]

Moist Heat or Steam Sterilization

[00193982194000]

Moist Heat or Steam Sterilization

[00193982194000]

Moist Heat or Steam Sterilization

[00193982194000]

Moist Heat or Steam Sterilization

[00193982194000]

Moist Heat or Steam Sterilization

[00193982194000]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-04-12
• Device Publish Date: 2021-04-02

On-Brand Devices [CORBEL]

• 00193982278540: CORBEL SPACER, 29 x 39, 21mm, 30°
• 00193982278533: CORBEL SPACER, 29 x 39, 21mm, 25°
• 00193982278526: CORBEL SPACER, 29 x 39, 19mm, 25°
• 00193982278519: CORBEL SPACER, 29 x 39, 17mm, 25°
• 00193982278502: CORBEL SPACER, 26 x 34, 21mm, 30°
• 00193982278496: CORBEL SPACER, 26 x 34, 19mm, 30°
• 00193982278489: CORBEL SPACER, 26 x 34, 17mm, 30°
• 00193982278472: CORBEL SPACER, 26 x 34, 21mm, 25°
• 00193982278465: CORBEL SPACER, 26 x 34, 19mm, 25°
• 00193982278458: CORBEL SPACER, 26 x 34, 17mm, 25°
• 00193982278441: CORBEL SPACER, 26 x 34, 15mm, 25°
• 00193982278427: CORBEL SPACER, 24 x 30, 21mm, 30°
• 00193982278410: CORBEL SPACER, 24 x 30, 19mm, 30°
• 00193982278403: CORBEL SPACER, 24 x 30, 17mm, 30°
• 00193982278397: CORBEL SPACER, 24 x 30, 15mm, 30°
• 00193982278373: CORBEL SPACER, 24 x 30, 21mm, 25°
• 00193982278366: CORBEL SPACER, 24 x 30, 19mm, 25°
• 00193982278359: CORBEL SPACER, 24 x 30, 17mm, 25°
• 00193982278342: CORBEL SPACER, 24 x 30, 15mm, 25°
• 00193982263379: Triple Barrel Anchor Guide, 15°, 21mm
• 00193982263362: Triple Barrel Anchor Guide, 15°, 19mm
• 00193982263355: Triple Barrel Anchor Guide, 15°, 17mm
• 00193982263348: Triple Barrel Anchor Guide, 15° 15mm
• 00193982263331: Triple Barrel Anchor Guide, 15°, 13mm
• 00193982263324: Triple Barrel Anchor Guide, 15°, 11mm
• 00193982263317: Threaded Rod, 15°
• 00193982263300: Anchor Impactor, 15°
• 00193982194109: Freehand Holder
• 00193982194093: CORBEL SPACER, 29 x 39, 21mm, 20°
• 00193982194086: CORBEL SPACER, 29 x 39, 19mm, 20°
• 00193982194079: CORBEL SPACER, 29 x 39, 17mm, 20°
• 00193982194062: CORBEL SPACER, 29 x 39, 15mm, 20°
• 00193982194055: CORBEL SPACER, 29 x 39, 21mm, 15°
• 00193982194048: CORBEL SPACER, 29 x 39, 19mm, 15°
• 00193982194031: CORBEL SPACER, 29 x 39, 17mm, 15°
• 00193982194024: CORBEL SPACER, 29 x 39, 15mm, 15°
• 00193982194017: CORBEL SPACER, 29 x 39, 13mm, 15°
• 00193982194000: CORBEL SPACER, 29 x 39, 21mm, 8°
• 00193982193997: CORBEL SPACER, 29 x 39, 19mm, 8°
• 00193982193980: CORBEL SPACER, 29 x 39, 17mm, 8°
• 00193982193973: CORBEL SPACER, 29 x 39, 15mm, 8°
• 00193982193966: CORBEL SPACER, 29 x 39, 13mm, 8°
• 00193982193959: CORBEL SPACER, 29 x 39, 11mm, 8°
• 00193982193942: CORBEL SPACER, 26 x 34, 21mm, 20°
• 00193982193935: CORBEL SPACER, 26 x 34, 19mm, 20°
• 00193982193928: CORBEL SPACER, 26 x 34, 17mm, 20°
• 00193982193911: CORBEL SPACER, 26 x 34, 15mm, 20°
• 00193982193904: CORBEL SPACER, 26 x 34, 13mm, 20°
• 00193982193898: CORBEL SPACER, 26 x 34, 21mm, 15°
• 00193982193881: CORBEL SPACER, 26 x 34, 19mm, 15°