C-VBR STGC-LCM19.75

GUDID 10888857403680

Corpectomy Cage, Lordotic, Size 12x14x19.75 mm

K2M, INC.

Vertebral body prosthesis

• Primary Device ID: 10888857403680
• NIH Device Record Key: 19ae7f46-e5ad-4a97-b852-ea5223cad2af
• Commercial Distribution Discontinuation: 2018-06-08
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: C-VBR
• Version Model Number: Lordotic-M-19.75
• Catalog Number: STGC-LCM19.75
• 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: false
• 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: 12 Millimeter
• Length: 12 Millimeter
• Length: 12 Millimeter
• Length: 12 Millimeter
• Length: 12 Millimeter
• Length: 12 Millimeter
• Length: 12 Millimeter
• Length: 12 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10888857403680 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152568

FDA Product Code

• PLR: Spinal vertebral body replacement device - Cervical

Sterilization

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

[10888857403680]

Moist Heat or Steam Sterilization

[10888857403680]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-24
• Device Publish Date: 2018-03-26

On-Brand Devices [C-VBR]

• 10888857403772: Corpectomy Cage, Lordotic, Size 12x14x39 mm
• 10888857403765: Corpectomy Cage, Lordotic, Size 12x14x35.5 mm
• 10888857403758: Corpectomy Cage, Lordotic, Size 12x14x32 mm
• 10888857403741: Corpectomy Cage, Lordotic, Size 12x14x30.25 mm
• 10888857403734: Corpectomy Cage, Lordotic, Size 12x14x28.5 mm
• 10888857403727: Corpectomy Cage, Lordotic, Size 12x14x26.75 mm
• 10888857403710: Corpectomy Cage, Lordotic, Size 12x14x25 mm
• 10888857403697: Corpectomy Cage, Lordotic, Size 12x14x21.5 mm
• 10888857403680: Corpectomy Cage, Lordotic, Size 12x14x19.75 mm
• 10888857403673: Corpectomy Cage, Lordotic, Size 12x14x18 mm
• 10888857403666: Corpectomy Cage, Lordotic, Size 10x12x39 mm
• 10888857403659: Corpectomy Cage, Lordotic, Size 10x12x35.5 mm
• 10888857403642: Corpectomy Cage, Lordotic, Size 10x12x32 mm
• 10888857403635: Corpectomy Cage, Lordotic, Size 10x12x30.25 mm
• 10888857403628: Corpectomy Cage, Lordotic, Size 10x12x28.5 mm
• 10888857403611: Corpectomy Cage, Lordotic, Size 10x12x26.75 mm
• 10888857403604: Corpectomy Cage, Lordotic, Size 10x12x25 mm
• 10888857403598: Corpectomy Cage, Lordotic, Size 10x12x23.25 mm
• 10888857403581: Corpectomy Cage, Lordotic, Size 10x12x21.5 mm
• 10888857403574: Corpectomy Cage, Lordotic, Size 10x12x19.75 mm
• 10888857403567: Corpectomy Cage, Lordotic, Size 10x12x18 mm
• 10888857403550: Corpectomy Cage, Parallel, Size 12x14x72 mm
• 10888857403543: Corpectomy Cage, Parallel, Size 12x14x65 mm
• 10888857403536: Corpectomy Cage, Parallel, Size 12x14x58 mm
• 10888857403529: Corpectomy Cage, Parallel, Size 12x14x51 mm
• 10888857403512: Corpectomy Cage, Parallel, Size 12x14x44 mm
• 10888857403505: Corpectomy Cage, Parallel, Size 12x14x37 mm
• 10888857403499: Corpectomy Cage, Parallel, Size 12x14x33.5 mm
• 10888857403482: Corpectomy Cage, Parallel, Size 12x14x30 mm
• 10888857403475: Corpectomy Cage, Parallel, Size 12x14x28.25 mm
• 10888857403468: Corpectomy Cage, Parallel, Size 12x14x26.5 mm
• 10888857403451: Corpectomy Cage, Parallel, Size 12x14x24.75 mm
• 10888857403444: Corpectomy Cage, Parallel, Size 12x14x23 mm
• 10888857403437: Corpectomy Cage, Parallel, Size 12x14x21.25 mm
• 10888857403420: Corpectomy Cage, Parallel, Size 12x14x19.5 mm
• 10888857403413: Corpectomy Cage, Parallel, Size 12x14x17.75 mm
• 10888857403406: Corpectomy Cage, Parallel, Size 12x14x16 mm
• 10888857403390: Corpectomy Cage, Parallel, Size 10x12x72 mm
• 10888857403383: Corpectomy Cage, Parallel, Size 10x12x65 mm
• 10888857403376: Corpectomy Cage, Parallel, Size 10x12x58 mm
• 10888857403369: Corpectomy Cage, Parallel, Size 10x12x51 mm
• 10888857403352: Corpectomy Cage, Parallel, Size 10x12x44 mm
• 10888857403345: Corpectomy Cage, Parallel, Size 10x12x37 mm
• 10888857403338: Corpectomy Cage, Parallel, Size 10x12x33.5 mm
• 10888857403321: Corpectomy Cage, Parallel, Size 10x12x30 mm
• 10888857403314: Corpectomy Cage, Parallel, Size 10x12x28.25 mm
• 10888857403307: Corpectomy Cage, Parallel, Size 10x12x26.5 mm
• 10888857403291: Corpectomy Cage, Parallel, Size 10x12x24.75 mm
• 10888857403284: Corpectomy Cage, Parallel, Size 10x12x23 mm
• 10888857403277: Corpectomy Cage, Parallel, Size 10x12x21.25 mm