Enza

GUDID B030CB0010100

8°, Lordotic, 26mm x 32mm,17mm

CAMBER SPINE TECHNOLOGIES, LLC

Polymeric spinal interbody fusion cage

• Primary Device ID: B030CB0010100
• NIH Device Record Key: 406d2e35-69ef-491f-bc78-5d21c7b8356b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Enza
• Version Model Number: CB-001-010
• 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
• Phone: 1-866-643-0739
• Email: customerservice@cambermedtech.com

Device Dimensions

• Depth: 32 Millimeter
• Depth: 32 Millimeter
• Depth: 32 Millimeter
• Depth: 32 Millimeter
• Depth: 32 Millimeter
• Depth: 32 Millimeter
• Depth: 32 Millimeter
• Depth: 32 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B030CB0010100 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153720

FDA Product Code

• OVD: Intervertebral Fusion Device With Integrated Fixation, Lumbar

Sterilization

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

[B030CB0010100]

Moist Heat or Steam Sterilization

[B030CB0010100]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-02-24
• Device Publish Date: 2016-09-20

On-Brand Devices [Enza]

• B030CC002380: Locking Set Screw
• B030CC002370: Locking Set Screw
• B030CC002360: Locking Set Screw
• B030CB0010390: Intervertebral Locking Plate , 32mm x 38mm
• B030CB0010380: Intervertebral Locking Plate , 26mm x 32mm
• B030CB0010370: Intervertebral Locking Plate , 23mm x 28mm
• B030CB0010350: 15°, Lordotic,32mm x 38mm,21mm
• B030CB0010340: 15°, Lordotic,32mm x 38mm,19mm
• B030CB0010330: 15°, Lordotic, 32mm x 38mm17mm
• B030CB0010320: 15°, Lordotic, 32mm x 38mm15mm
• B030CB0010310: 15°, Lordotic, 32mm x 38mm13mm
• B030CB0010300: 15°, Lordotic, 26mm x 32mm,21mm
• B030CB0010290: 15°, Lordotic, 26mm x 32mm,19mm
• B030CB0010280: 15°, Lordotic, 26mm x 32mm,17mm
• B030CB0010270: 15°, Lordotic, 26mm x 32mm,15mm
• B030CB0010260: 15°, Lordotic, 26mm x 32mm,13mm
• B030CB0010250: 15°, Lordotic, 26mm x 32mm,11mm
• B030CB0010220: 15°, Lordotic, 23mm x 28mm,17mm
• B030CB0010210: 15°, Lordotic, 23mm x 28mm,15mm
• B030CB0010200: 15°, Lordotic, 23mm x 28mm,13mm
• B030CB0010190: 15°, Lordotic, 23mm x 28mm,11mm
• B030CB0010180: 8°, Lordotic, 32mm x 38mm,21mm
• B030CB0010170: 8°, Lordotic, 32mm x 38mm,19mm
• B030CB0010160: 8°, Lordotic, 32mm x 38mm,17mm
• B030CB0010150: 8°, Lordotic, 32mm x 38mm,15mm
• B030CB0010140: 8°, Lordotic, 32mm x 38mm,13mm
• B030CB0010130: 8°, Lordotic, 32mm x 38mm,11mm
• B030CB0010120: 8°, Lordotic, 26mm x 32mm,21mm
• B030CB0010110: 8°, Lordotic, 26mm x 32mm,19mm
• B030CB0010100: 8°, Lordotic, 26mm x 32mm,17mm
• B030CB0010090: 8°, Lordotic, 26mm x 32mm,15mm
• B030CB0010080: 8°, Lordotic, 26mm x 32mm,13mm
• B030CB0010070: 8°, Lordotic, 26mm x 32mm, 11mm
• B030CB0010040: 8°, Lordotic, 23mm x 28mm, 17mm
• B030CB0010030: 8°, Lordotic, 23mm x 28mm, 15mm
• B030CB0010020: 8°, Lordotic, 23mm x 28mm, 13mm
• B030CB0010010: 8°, Lordotic, 23mm x 28mm, 11mm