Foundation Surgical Interwedge LB22451215

GUDID 00810141045958

Interwedge, 22W x 45L x 12H x 15L°, Sterile (x1)

FOUNDATION SURGICAL GROUP INC

Metallic spinal interbody fusion cage

• Primary Device ID: 00810141045958
• NIH Device Record Key: 0e0a8a8f-4386-48a3-b05b-e7b5b7ae790a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Foundation Surgical Interwedge
• Version Model Number: LB22451215
• Catalog Number: LB22451215
• Company DUNS: 119029419
• Company Name: FOUNDATION SURGICAL GROUP 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: true
• Expiration Date: true
• 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: 727-209-7436
• Email: Foundationsurgical@orthoex.com
• Phone: 727-209-7436
• Email: Foundationsurgical@orthoex.com
• Phone: 727-209-7436
• Email: Foundationsurgical@orthoex.com
• Phone: 727-209-7436
• Email: Foundationsurgical@orthoex.com
• Phone: 727-209-7436
• Email: Foundationsurgical@orthoex.com
• Phone: 727-209-7436
• Email: Foundationsurgical@orthoex.com
• Phone: 727-209-7436
• Email: Foundationsurgical@orthoex.com
• Phone: 727-209-7436
• Email: Foundationsurgical@orthoex.com
• Phone: 727-209-7436
• Email: Foundationsurgical@orthoex.com
• Phone: 727-209-7436
• Email: Foundationsurgical@orthoex.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810141045958 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241487

FDA Product Code

• OVD: Intervertebral Fusion Device With Integrated Fixation, Lumbar

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-09-16
• Device Publish Date: 2025-09-08

On-Brand Devices [Foundation Surgical Interwedge]

• 00810141045972: Interwedge, 22W x 55L x 12H x 15L°, Sterile (x1)
• 00810141045965: Interwedge, 22W x 50L x 12H x 15L°, Sterile (x1)
• 00810141045958: Interwedge, 22W x 45L x 12H x 15L°, Sterile (x1)
• 00810141045873: Interwedge, 22W x 55L x 12H x 10L°, Sterile (x1)
• 00810141045866: Interwedge, 22W x 50L x 12H x 10L°, Sterile (x1)
• 00810141045859: Interwedge, 22W x 45L x 12H x 10L°, Sterile (x1)
• 00810141045675: Interwedge, 22W x 55L x 10H x 10L°, Sterile (x1)
• 00810141045668: Interwedge, 22W x 50L x 10H x 10L°, Sterile (x1)
• 00810141045651: Interwedge, 22W x 45L x 10H x 10L°, Sterile (x1)
• 00810141045521: Interwedge, 22W x 55L x 8H x 3L°, Sterile (x1)
• 00810141045514: Interwedge, 22W x 50L x 8H x 3L°, Sterile (x1)
• 00810141045507: Interwedge, 22W x 45L x 8H x 3L°, Sterile (x1)