CAPRI™ Corpectomy Cage System 7501-21636L15-G2

GUDID 10888857334052

Solid Corpectomy Cage, Size 13x16x36 mm, 15°

K2M, INC.

Vertebral body prosthesis

• Primary Device ID: 10888857334052
• NIH Device Record Key: a5b54ec7-e3bd-4171-bbf5-ec38f4f95cf0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CAPRI™ Corpectomy Cage System
• Version Model Number: 7501-21636L15-G2
• Catalog Number: 7501-21636L15-G2
• Company DUNS: 146060863
• Company Name: K2M, 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(703)777-3155
• Email: sgilbert@k2m.com
• Phone: +1(703)777-3155
• Email: sgilbert@k2m.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com

Device Dimensions

• Angle: 15 degree
• Angle: 15 degree
• Angle: 15 degree
• Angle: 15 degree
• Angle: 15 degree
• Angle: 15 degree
• Angle: 15 degree
• Angle: 15 degree
• Width: 16 Millimeter
• Height: 36 Millimeter
• Length: 13 Millimeter
• Angle: 15 degree
• Width: 16 Millimeter
• Height: 36 Millimeter
• Length: 13 Millimeter
• Angle: 15 degree
• Width: 16 Millimeter
• Height: 36 Millimeter
• Length: 13 Millimeter
• Angle: 15 degree
• Width: 16 Millimeter
• Height: 36 Millimeter
• Length: 13 Millimeter
• Angle: 15 degree
• Width: 16 Millimeter
• Height: 36 Millimeter
• Length: 13 Millimeter
• Angle: 15 degree
• Width: 16 Millimeter
• Height: 36 Millimeter
• Length: 13 Millimeter
• Angle: 15 degree
• Width: 16 Millimeter
• Height: 36 Millimeter
• Length: 13 Millimeter
• Angle: 15 degree
• Width: 16 Millimeter
• Height: 36 Millimeter
• Length: 13 Millimeter
• Angle: 15 degree
• Width: 16 Millimeter
• Height: 36 Millimeter
• Length: 13 Millimeter
• Angle: 15 degree
• Width: 16 Millimeter
• Height: 36 Millimeter
• Length: 13 Millimeter
• Angle: 15 degree
• Width: 16 Millimeter
• Height: 36 Millimeter
• Length: 13 Millimeter
• Angle: 15 degree
• Width: 16 Millimeter
• Height: 36 Millimeter
• Length: 13 Millimeter
• Angle: 15 degree
• Width: 16 Millimeter
• Height: 36 Millimeter
• Length: 13 Millimeter
• Angle: 15 degree
• Width: 16 Millimeter
• Height: 36 Millimeter
• Length: 13 Millimeter
• Angle: 15 degree
• Width: 16 Millimeter
• Height: 36 Millimeter
• Length: 13 Millimeter
• Angle: 15 degree
• Width: 16 Millimeter
• Height: 36 Millimeter
• Length: 13 Millimeter
• Angle: 15 degree
• Width: 16 Millimeter
• Height: 36 Millimeter
• Length: 13 Millimeter
• Angle: 15 degree
• Width: 16 Millimeter
• Height: 36 Millimeter
• Length: 13 Millimeter
• Angle: 15 degree

Device Identifiers

Device Issuing Agency	Device ID
GS1	10888857334052 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170055

FDA Product Code

• MQP: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-24
• Device Publish Date: 2017-04-26

On-Brand Devices [CAPRI™ Corpectomy Cage System]

• 10888857371491: Locking Screw - Angle
• 10888857371484: Locking Screw - Height
• 10888857371118: Corpectomy Cage with Set Screw, Size 14x18mm, 20-24mm, 0°, 0-20°
• 10888857371101: Corpectomy Cage with Set Screw, Size 13x16mm, 20-24mm, 0°, 0-20°
• 10888857371088: Corpectomy Cage with Set Screw, Size 14x18mm, 18-21mm, 0°, 0-20°
• 10888857371071: Corpectomy Cage with Set Screw, Size 13x16mm, 18-21mm, 0°, 0-20°
• 10888857371033: Corpectomy Cage with Set Screw, Size 14x18mm, 58-74mm, 10°, 0-20°
• 10888857371026: Corpectomy Cage with Set Screw, Size 14x18mm, 58-74mm, 5°, 0-20°
• 10888857371019: Corpectomy Cage with Set Screw, Size 14x18mm, 58-74mm, 0°, 0-20°
• 10888857371002: Corpectomy Cage with Set Screw, Size 13x16mm, 58-74mm, 10°, 0-20°
• 10888857370999: Corpectomy Cage with Set Screw, Size 13x16mm, 58-74mm, 5°, 0-20°
• 10888857370982: Corpectomy Cage with Set Screw, Size 13x16mm, 58-74mm, 0°, 0-20°
• 10888857370951: Corpectomy Cage with Set Screw, Size 14x18mm, 26-36mm, 0°, 0-20°
• 10888857370944: Corpectomy Cage with Set Screw, Size 13x16mm, 26-36mm, 0°, 0-20°
• 10888857370791: Corpectomy Cage with Set Screw, Size 14x18mm, 32-46mm, 5°, 0-20°
• 10888857370784: Corpectomy Cage with Set Screw, Size 14x18mm, 32-46mm, 0°, 0-20°
• 10888857370777: Corpectomy Cage with Set Screw, Size 13x16mm, 32-46mm, 5°, 0-20°
• 10888857370760: Corpectomy Cage with Set Screw, Size 13x16mm, 32-46mm, 0°, 0-20°
• 10888857370722: Corpectomy Cage with Set Screw, Size 14x18mm, 38-54mm, 10°, 0-20°
• 10888857370715: Corpectomy Cage with Set Screw, Size 14x18mm, 38-54mm, 5°, 0-20°
• 10888857370708: Corpectomy Cage with Set Screw, Size 14x18mm, 38-54mm, 0°, 0-20°
• 10888857370692: Corpectomy Cage with Set Screw, Size 13x16mm, 38-54mm, 10°, 0-20°
• 10888857370685: Corpectomy Cage with Set Screw, Size 13x16mm, 38-54mm, 5°, 0-20°
• 10888857370678: Corpectomy Cage with Set Screw, Size 13x16mm, 38-54mm, 0°, 0-20°
• 10888857370630: Corpectomy Cage with Set Screw, Size 14x18mm, 48-64mm, 10°, 0-20°
• 10888857370623: Corpectomy Cage with Set Screw, Size 14x18mm, 48-64mm, 5°, 0-20°
• 10888857370616: Corpectomy Cage with Set Screw, Size 14x18mm, 48-64mm, 0°, 0-20°
• 10888857370609: Corpectomy Cage with Set Screw, Size 13x16mm, 48-64mm, 10°, 0-20°
• 10888857370593: Corpectomy Cage with Set Screw, Size 13x16mm, 48-64mm, 5°, 0-20°
• 10888857370586: Corpectomy Cage with Set Screw, Size 13x16mm, 48-64mm, 0°, 0-20°
• 10888857370562: Corpectomy Cage with Set Screw, Size 14x18mm, 22-28mm, 0°, 0-20°
• 10888857370555: Corpectomy Cage with Set Screw, Size 13x16mm, 22-28mm, 0°, 0-20°
• 10888857361935: Expandable Implant Inserter
• 10888857361928: Tapered Driver, Size Size 10
• 10888857361911: Driver Height/Angle
• 10888857361904: Non-Tapered Driver, Size Size 10
• 10888857361874: Angle Adjustment Guide, Size 13x16 mm, 14x18mm
• 10888857361867: Angle Adjustment Guide, Size 16x20mm
• 10888857341456: Solid Corpectomy Cage, Size 16x20x50 mm, 7°
• 10888857341449: Solid Corpectomy Cage, Size 16x20x50 mm, 30°
• 10888857341432: Solid Corpectomy Cage, Size 16x20x50 mm, 25°
• 10888857341425: Solid Corpectomy Cage, Size 16x20x50 mm, 20°
• 10888857341418: Solid Corpectomy Cage, Size 16x20x50 mm, 15°
• 10888857341401: Solid Corpectomy Cage, Size 16x20x50 mm, 12°
• 10888857341395: Solid Corpectomy Cage, Size 16x20x50 mm, 0°
• 10888857341388: Solid Corpectomy Cage, Size 16x20x50 mm, 0°/7°
• 10888857341371: Solid Corpectomy Cage, Size 16x20x49 mm, 7°
• 10888857341364: Solid Corpectomy Cage, Size 16x20x49 mm, 30°
• 10888857341357: Solid Corpectomy Cage, Size 16x20x49 mm, 25°
• 10888857341340: Solid Corpectomy Cage, Size 16x20x49 mm, 20°