CASCADIA™ Interbody System 6101-2324210AL10-G2

GUDID 10888857415744

AL Interbody, Size 32x42mm, A=10mm, P=7mm, 10 Degrees

K2M, INC.

Vertebral body prosthesis

• Primary Device ID: 10888857415744
• NIH Device Record Key: 2fec493b-9209-4dcd-b92b-25ec1c3d8022
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CASCADIA™ Interbody System
• Version Model Number: 6101-2324210AL10-G2
• Catalog Number: 6101-2324210AL10-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: mzellers@k2m.com
• Phone: +1(703)777-3155
• Email: mzellers@k2m.com

Device Dimensions

• Length: 32 Millimeter
• Length: 32 Millimeter
• Length: 32 Millimeter
• Length: 32 Millimeter
• Length: 32 Millimeter
• Length: 32 Millimeter
• Length: 32 Millimeter
• Length: 32 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10888857415744 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172009

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-02-24
• Device Publish Date: 2018-12-21

On-Brand Devices [CASCADIA™ Interbody System]

• 10888857421899: AL Interbody, Size 32x42mm, A=21mm, P=12mm, 20 Degrees
• 10888857421882: AL Interbody, Size 32x42mm, A=20mm, P=11mm, 20 Degrees
• 10888857421875: AL Interbody, Size 32x42mm, A=19mm, P=10mm, 20 Degrees
• 10888857421868: AL Interbody, Size 32x42mm, A=18mm, P=9mm, 20 Degrees
• 10888857421851: AL Interbody, Size 32x42mm, A=17mm, P=8mm, 20 Degrees
• 10888857421844: AL Interbody, Size 32x42mm, A=16mm, P=7mm, 20 Degrees
• 10888857421837: AL Interbody, Size 32x42mm, A=15mm, P=6mm, 20 Degrees
• 10888857415775: AL Interbody, Size 32x42mm, A=9mm, P=6mm, 10 Degrees
• 10888857415768: AL Interbody, Size 32x42mm, A=9mm, P=7mm, 5 Degrees
• 10888857415751: AL Interbody Convex, Size 32x42mm, A=9mm, P=9mm
• 10888857415744: AL Interbody, Size 32x42mm, A=10mm, P=7mm, 10 Degrees
• 10888857415737: AL Interbody, Size 32x42mm, A=10mm, P=8mm, 5 Degrees
• 10888857415720: AL Interbody Convex, Size 32x42mm, A=10mm, P=10mm
• 10888857415713: AL Interbody, Size 32x42mm, A=11mm, P=8mm, 10 Degrees
• 10888857415706: AL Interbody, Size 32x42mm, A=11mm, P=9mm, 5 Degrees
• 10888857415690: AL Interbody Convex, Size 32x42mm, A=11mm, P=11mm
• 10888857415683: AL Interbody, Size 32x42mm, A=12mm, P=9mm, 10 Degrees
• 10888857415676: AL Interbody, Size 32x42mm, A=12mm, P=10mm, 5 Degrees
• 10888857415669: AL Interbody Convex, Size 32x42mm, A=12mm, P=12mm
• 10888857415652: AL Interbody, Size 32x42mm, A=13mm, P=10mm, 10 Degrees
• 10888857415645: AL Interbody, Size 32x42mm, A=13mm, P=11mm, 5 Degrees
• 10888857415638: AL Interbody Convex, Size 32x42mm, A=13mm, P=13mm
• 10888857415621: AL Interbody, Size 32x42mm, A=18mm, P=12mm, 15 Degrees
• 10888857415614: AL Interbody, Size 32x42mm, A=14mm, P=11mm, 10 Degrees
• 10888857415607: AL Interbody, Size 32x42mm, A=14mm, P=12mm, 5 Degrees
• 10888857415591: AL Interbody Convex, Size 32x42mm, A=14mm, P=14mm
• 10888857415584: AL Interbody, Size 32x42mm, A=19mm, P=13mm, 15 Degrees
• 10888857415577: AL Interbody, Size 32x42mm, A=15mm, P=12mm, 10 Degrees
• 10888857415560: AL Interbody, Size 32x42mm, A=15mm, P=13mm, 5 Degrees
• 10888857415553: AL Interbody Convex, Size 32x42mm, A=15mm, P=15mm
• 10888857415546: AL Interbody, Size 32x42mm, A=20mm, P=14mm, 15 Degrees
• 10888857415539: AL Interbody, Size 32x42mm, A=16mm, P=13mm, 10 Degrees
• 10888857415522: AL Interbody, Size 32x42mm, A=16mm, P=14mm, 5 Degrees
• 10888857415515: AL Interbody Convex, Size 32x42mm, A=16mm, P=16mm
• 10888857415508: AL Interbody, Size 32x42mm, A=21mm, P=15mm, 15 Degrees
• 10888857415492: AL Interbody, Size 32x42mm, A=13mm, P=7mm, 15 Degrees
• 10888857415485: AL Interbody, Size 32x42mm, A=17mm, P=14mm, 10 Degrees
• 10888857415478: AL Interbody, Size 32x42mm, A=17mm, P=15mm, 5 Degrees
• 10888857415461: AL Interbody Convex, Size 32x42mm, A=17mm, P=17mm
• 10888857415454: AL Interbody, Size 32x42mm, A=14mm, P=8mm, 15 Degrees
• 10888857415447: AL Interbody, Size 32x42mm, A=18mm, P=15mm, 10 Degrees
• 10888857415430: AL Interbody, Size 32x42mm, A=18mm, P=16mm, 5 Degrees
• 10888857415423: AL Interbody Convex, Size 32x42mm, A=18mm, P=18mm
• 10888857415416: AL Interbody, Size 32x42mm, A=15mm, P=9mm, 15 Degrees
• 10888857415409: AL Interbody, Size 32x42mm, A=19mm, P=16mm, 10 Degrees
• 10888857415393: AL Interbody, Size 32x42mm, A=19mm, P=17mm, 5 Degrees
• 10888857415386: AL Interbody Convex, Size 32x42mm, A=19mm, P=19mm
• 10888857415379: AL Interbody, Size 32x42mm, A=16mm, P=10mm, 15 Degrees
• 10888857415362: AL Interbody, Size 32x42mm, A=20mm, P=17mm, 10 Degrees
• 10888857415355: AL Interbody, Size 32x42mm, A=20mm, P=18mm, 5 Degrees