Innovasis® Cranial System C2DY16006

GUDID M711C2DY160060

CP Ti

INNO Holdings, Inc.

Cranioplasty plate, alterable

• Primary Device ID: M711C2DY160060
• NIH Device Record Key: 67d7f619-ab80-4540-995c-0f822e389e4b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Innovasis® Cranial System
• Version Model Number: C2DY16006
• Catalog Number: C2DY16006
• 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: 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: 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 Identifiers

Device Issuing Agency	Device ID
HIBCC	M711C2DY160060 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141644

FDA Product Code

• GWO: Plate, Cranioplasty, Preformed, Alterable

Sterilization

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

[M711C2DY160060]

Moist Heat or Steam Sterilization

[M711C2DY160060]

Moist Heat or Steam Sterilization

[M711C2DY160060]

Moist Heat or Steam Sterilization

[M711C2DY160060]

Moist Heat or Steam Sterilization

[M711C2DY160060]

Moist Heat or Steam Sterilization

[M711C2DY160060]

Moist Heat or Steam Sterilization

[M711C2DY160060]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2025-12-17
• Device Publish Date: 2014-12-29

On-Brand Devices [Innovasis® Cranial System]

• M711LS2700: LS-270
• M711LS2690: LS-269
• M711LS2680: LS-268
• M711LS2670: LS-267
• M711LS2660: LS-266
• M711C5SS190040: Ti 6Al 4V (ELI)
• M711C5SD160050: Ti 6Al 4V (ELI)
• M711C5SD160040: Ti 6Al 4V (ELI)
• M711C5SD160030: Ti 6Al 4V (ELI)
• M711C3DM061000: CP Ti
• M711C2ST161020: CP Ti
• M711C2ST160120: CP Ti
• M711C2ST160060: CP Ti
• M711C2ST160020: CP Ti
• M711C2SQ160040: CP Ti
• M711C2DY160060: CP Ti
• M711C2BR162260: CP Ti
• M711C2BR162250: CP Ti
• M711C2BR161560: CP Ti
• M711C2BR161550: CP Ti
• M711BTA990: BTA-99
• M711BTA1000: BTA-100