True Position® Spacer System 1208-01-3015

GUDID 10840642107623

Implant, Lordotic, 30 (L) x 15 (H) mm, 7°

Spine Wave, Inc.

Metal-polymer composite spinal interbody fusion cage

• Primary Device ID: 10840642107623
• NIH Device Record Key: 95ee7ba8-54db-4d9e-94fb-55437c1d59e9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: True Position® Spacer System
• Version Model Number: 1208-01-3015
• Catalog Number: 1208-01-3015
• Company DUNS: 067789763
• Company Name: Spine Wave, 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: 203-944-9494
• Email: GUDID@spinewave.com

Device Dimensions

• Height: 15 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10840642107623 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100743

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

[10840642107623]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-02-24
• Device Publish Date: 2016-09-24

On-Brand Devices [True Position® Spacer System]

• 10840642107890: XL Implant Inserter Assembly
• 10840642107883: Implant Inserter
• 10840642107722: Implant, 36 (L) x 7.5 (H) mm
• 10840642107715: Implant, 30 (L) x 7.5 (H) mm
• 10840642107708: Implant, 27 (L) x 7.5 (H) mm
• 10840642107692: Implant, Lordotic, 36 (L) x 15 (H) mm, 7°
• 10840642107685: Implant, Lordotic, 36 (L) x 14 (H) mm, 7°
• 10840642107678: Implant, Lordotic, 36 (L) x 13 (H) mm, 7°
• 10840642107661: Implant, Lordotic, 36 (L) x 12 (H) mm, 7°
• 10840642107654: Implant, Lordotic, 36 (L) x 11 (H) mm, 7°
• 10840642107647: Implant, Lordotic, 36 (L) x 10 (H) mm, 7°
• 10840642107630: Implant, Lordotic, 36 (L) x 9 (H) mm, 7°
• 10840642107623: Implant, Lordotic, 30 (L) x 15 (H) mm, 7°
• 10840642107616: Implant, Lordotic, 30 (L) x 14 (H) mm, 7°
• 10840642107609: Implant, Lordotic, 30 (L) x 13 (H) mm, 7°
• 10840642107593: Implant, Lordotic, 30 (L) x 12 (H) mm, 7°
• 10840642107586: Implant, Lordotic, 30 (L) x 11 (H) mm, 7°
• 10840642107579: Implant, Lordotic, 30 (L) x 10 (H) mm, 7°
• 10840642107562: Implant, Lordotic, 30 (L) x 9 (H) mm, 7°
• 10840642107555: Implant, Lordotic, 27 (L) x 15 (H) mm, 7°
• 10840642107548: Implant, Lordotic, 27 (L) x 14 (H) mm, 7°
• 10840642107531: Implant, Lordotic, 27 (L) x 13 (H) mm, 7°
• 10840642107524: Implant, Lordotic, 27 (L) x 12 (H) mm, 7°
• 10840642107517: Implant, Lordotic, 27 (L) x 11 (H) mm, 7°
• 10840642107500: Implant, Lordotic, 27 (L) x 10 (H) mm, 7°
• 10840642107494: Implant, Lordotic, 27 (L) x 9 (H) mm, 7°