SPIRA-O Open Matrix OLIF

GUDID B030SPO263208170

Bi-Convex 8° Lordotic, 26mm x 32mm, 17mm

CAMBER SPINE TECHNOLOGIES, LLC

Metallic spinal fusion cage, non-sterile

• Primary Device ID: B030SPO263208170
• NIH Device Record Key: eace9a70-640d-42ef-be18-a6ba8ca647f8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SPIRA-O Open Matrix OLIF
• Version Model Number: SPO-2632-0817
• Company DUNS: 054205979
• Company Name: CAMBER SPINE TECHNOLOGIES, LLC
• 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: 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: 1-866-643-0739
• Email: customerservice@cambermedtech.com

Device Dimensions

• Width: 32 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B030SPO263208170 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162986

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

[B030SPO263208170]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-02-05
• Device Publish Date: 2019-07-17

On-Brand Devices [ SPIRA-O Open Matrix OLIF]

• B030SPO303820190: Bi-Convex 20° Lordotic, 30mm x 38mm, 19mm
• B030SPO303820170: Bi-Convex 20° Lordotic, 30mm x 38mm, 17mm
• B030SPO303820150: Bi-Convex 20° Lordotic, 30mm x 38mm, 15mm
• B030SPO303820130: Bi-Convex 20° Lordotic, 30mm x 38mm, 13mm
• B030SPO303815190: Bi-Convex 15° Lordotic, 30mm x 38mm, 19mm
• B030SPO303815170: Bi-Convex 15° Lordotic, 30mm x 38mm, 17mm
• B030SPO303815150: Bi-Convex 15° Lordotic, 30mm x 38mm, 15mm
• B030SPO303815130: Bi-Convex 15° Lordotic, 30mm x 38mm, 13mm
• B030SPO303815110: Bi-Convex 15° Lordotic, 30mm x 38mm, 11mm
• B030SPO303808190: Bi-Convex 8° Lordotic, 30mm x 38mm, 19mm
• B030SPO303808170: Bi-Convex 8° Lordotic, 30mm x 38mm, 17mm
• B030SPO303808150: Bi-Convex 8° Lordotic, 30mm x 38mm, 15mm
• B030SPO303808130: Bi-Convex 8° Lordotic, 30mm x 38mm, 13mm
• B030SPO303808110: Bi-Convex 8° Lordotic, 30mm x 38mm, 11mm
• B030SPO303808090: Bi-Convex 8° Lordotic, 30mm x 38mm, 9mm
• B030SPO263220170: Bi-Convex 20° Lordotic, 26mm x 32mm, 17mm
• B030SPO263220150: Bi-Convex 20° Lordotic, 26mm x 32mm, 15mm
• B030SPO263220130: Bi-Convex 20° Lordotic, 26mm x 32mm, 13mm
• B030SPO263220110: Bi-Convex 20° Lordotic, 26mm x 32mm, 11mm
• B030SPO263215170: Bi-Convex 15° Lordotic, 26mm x 32mm, 17mm
• B030SPO263215150: Bi-Convex 15° Lordotic, 26mm x 32mm, 15mm
• B030SPO263215130: Bi-Convex 15° Lordotic, 26mm x 32mm, 13mm
• B030SPO263215110: Bi-Convex 15° Lordotic, 26mm x 32mm, 11mm
• B030SPO263208170: Bi-Convex 8° Lordotic, 26mm x 32mm, 17mm
• B030SPO263208150: Bi-Convex 8° Lordotic, 26mm x 32mm, 15mm
• B030SPO263208130: Bi-Convex 8° Lordotic, 26mm x 32mm, 13mm
• B030SPO263208110: Bi-Convex 8° Lordotic, 26mm x 32mm, 11mm
• B030SPO263208090: Bi-Convex 8° Lordotic, 26mm x 32mm, 9mm