Px™ X21216320

GUDID M711X212163200

PEEK, Ta

Innovasis, Inc.

Polymeric spinal interbody fusion cage

• Primary Device ID: M711X212163200
• NIH Device Record Key: e4dbf360-2f31-498c-9e67-36db71bee9ac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Px™
• Version Model Number: X21216320
• Catalog Number: X21216320
• Company DUNS: 156567492
• Company Name: Innovasis, 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

Device Dimensions

• Width: 12 Millimeter
• Angle: 0 degree
• Length: 32 Millimeter
• Height: 16 Millimeter
• Width: 12 Millimeter
• Angle: 0 degree
• Length: 32 Millimeter
• Height: 16 Millimeter
• Width: 12 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M711X212163200 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150500

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

[M711X212163200]

Moist Heat or Steam Sterilization

[M711X212163200]

Moist Heat or Steam Sterilization

[M711X212163200]

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: 2015-07-16

On-Brand Devices [Px™]

• M711X212163200: PEEK, Ta
• M711X212163000: PEEK, Ta
• M711X212162800: PEEK, Ta
• M711X212153200: PEEK, Ta
• M711X212153000: PEEK, Ta
• M711X212152800: PEEK, Ta
• M711X212143200: PEEK, Ta
• M711X212143000: PEEK, Ta
• M711X212142800: PEEK, Ta
• M711X212133200: PEEK, Ta
• M711X212133000: PEEK, Ta
• M711X212132800: PEEK, Ta
• M711X212123200: PEEK, Ta
• M711X212123000: PEEK, Ta
• M711X212122800: PEEK, Ta
• M711X212113200: PEEK, Ta
• M711X212113000: PEEK, Ta
• M711X212112800: PEEK, Ta
• M711X212103200: PEEK, Ta
• M711X212103000: PEEK, Ta
• M711X212102800: PEEK, Ta
• M711X212093200: PEEK, Ta
• M711X212093000: PEEK, Ta
• M711X212092800: PEEK, Ta
• M711X212082800: PEEK, Ta
• M711X210162550: PEEK, Ta
• M711X210162500: PEEK, Ta
• M711X210162250: PEEK, Ta
• M711X210162200: PEEK, Ta
• M711X210153200: PEEK, Ta
• M711X210152800: PEEK, Ta
• M711X210152550: PEEK, Ta
• M711X210152500: PEEK, Ta
• M711X210152250: PEEK, Ta
• M711X210152200: PEEK, Ta
• M711X210143200: PEEK, Ta
• M711X210142800: PEEK, Ta
• M711X210142550: PEEK, Ta
• M711X210142500: PEEK, Ta
• M711X210142250: PEEK, Ta
• M711X210142200: PEEK, Ta
• M711X210133200: PEEK, Ta
• M711X210132800: PEEK, Ta
• M711X210132550: PEEK, Ta
• M711X210132500: PEEK, Ta
• M711X210132250: PEEK, Ta
• M711X210132200: PEEK, Ta
• M711X210123200: PEEK, Ta
• M711X210122800: PEEK, Ta
• M711X210122550: PEEK, Ta