CxHA™ LS-457-07

GUDID M711LS457070

SST

INNO Holdings, Inc.

Spinal implant trial

• Primary Device ID: M711LS457070
• NIH Device Record Key: 683bb58d-7389-414d-b7c6-2c7eba7d4688
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CxHA™
• Version Model Number: LS-457-07
• Catalog Number: LS-457-07
• Company DUNS: 141620464
• Company Name: INNO Holdings, Inc.
• Device Count: 1
• DM Exempt: true
• 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: false
• Lot Batch: false
• Serial Number: true
• 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: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com

Device Dimensions

• Length: 16 Millimeter
• Width: 18 Millimeter
• Height: 12 Millimeter
• Angle: 8 degree
• Length: 16 Millimeter
• Width: 18 Millimeter
• Height: 12 Millimeter
• Angle: 8 degree
• Length: 16 Millimeter
• Width: 18 Millimeter
• Height: 12 Millimeter
• Angle: 8 degree
• Length: 16 Millimeter
• Width: 18 Millimeter
• Height: 12 Millimeter
• Angle: 8 degree
• Length: 16 Millimeter
• Width: 18 Millimeter
• Height: 12 Millimeter
• Angle: 8 degree
• Length: 16 Millimeter
• Width: 18 Millimeter
• Height: 12 Millimeter
• Angle: 8 degree
• Length: 16 Millimeter
• Width: 18 Millimeter
• Height: 12 Millimeter
• Angle: 8 degree
• Length: 16 Millimeter
• Width: 18 Millimeter
• Height: 12 Millimeter
• Angle: 8 degree
• Length: 16 Millimeter
• Width: 18 Millimeter
• Height: 12 Millimeter
• Angle: 8 degree
• Length: 16 Millimeter
• Width: 18 Millimeter
• Height: 12 Millimeter
• Angle: 8 degree

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M711LS457070 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181115

FDA Product Code

• ODP: Intervertebral Fusion Device With Bone Graft, Cervical

Sterilization

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

[M711LS457070]

Moist Heat or Steam Sterilization

[M711LS457070]

Moist Heat or Steam Sterilization

[M711LS457070]

Moist Heat or Steam Sterilization

[M711LS457070]

Moist Heat or Steam Sterilization

[M711LS457070]

Moist Heat or Steam Sterilization

[M711LS457070]

Moist Heat or Steam Sterilization

[M711LS457070]

Moist Heat or Steam Sterilization

[M711LS457070]

Moist Heat or Steam Sterilization

[M711LS457070]

Moist Heat or Steam Sterilization

[M711LS457070]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2025-12-17
• Device Publish Date: 2018-09-30

On-Brand Devices [CxHA™]

• M711LS4590: Polypropylene
• M711LS457080: SST
• M711LS457070: SST
• M711LS457060: SST
• M711LS457050: SST
• M711LS457040: SST
• M711LS457030: SST
• M711LS457020: SST
• M711LS457010: SST
• M711LS4550: SST
• M711LS4540: SST
• M711CH1417091: HA PEEK, Ta