Enza-O

GUDID B030EZO303815130

ENZA®-O 30mm x 38mm, 15° Lordotic, 13mm

CAMBER SPINE TECHNOLOGIES, LLC

Metallic spinal interbody fusion cage

• Primary Device ID: B030EZO303815130
• NIH Device Record Key: f02e16bc-5750-442a-96eb-a1d32464d9ca
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Enza-O
• Version Model Number: EZO-3038-1513
• 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: 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: +1(484) 427-7060
• Email: quality@cambermedtech.com
• Phone: +1(484) 427-7060
• Email: quality@cambermedtech.com
• Phone: +1(484) 427-7060
• Email: quality@cambermedtech.com
• Phone: +1(484) 427-7060
• Email: quality@cambermedtech.com
• Phone: +1(484) 427-7060
• Email: quality@cambermedtech.com
• Phone: +1(484) 427-7060
• Email: quality@cambermedtech.com
• Phone: +1(484) 427-7060
• Email: quality@cambermedtech.com
• Phone: +1(484) 427-7060
• Email: quality@cambermedtech.com
• Phone: +1(484) 427-7060
• Email: quality@cambermedtech.com
• Phone: +1(484) 427-7060
• Email: quality@cambermedtech.com
• Phone: +1(484) 427-7060
• Email: quality@cambermedtech.com
• Phone: +1(484) 427-7060
• Email: quality@cambermedtech.com
• Phone: +1(484) 427-7060
• Email: quality@cambermedtech.com
• Phone: +1(484) 427-7060
• Email: quality@cambermedtech.com
• Phone: +1(484) 427-7060
• Email: quality@cambermedtech.com
• Phone: +1(484) 427-7060
• Email: quality@cambermedtech.com
• Phone: +1(484) 427-7060
• Email: quality@cambermedtech.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B030EZO303815130 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221324

FDA Product Code

• OVD: Intervertebral Fusion Device With Integrated Fixation, Lumbar

Sterilization

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

[B030EZO303815130]

Moist Heat or Steam Sterilization

[B030EZO303815130]

Moist Heat or Steam Sterilization

[B030EZO303815130]

Moist Heat or Steam Sterilization

[B030EZO303815130]

Moist Heat or Steam Sterilization

[B030EZO303815130]

Moist Heat or Steam Sterilization

[B030EZO303815130]

Moist Heat or Steam Sterilization

[B030EZO303815130]

Moist Heat or Steam Sterilization

[B030EZO303815130]

Moist Heat or Steam Sterilization

[B030EZO303815130]

Moist Heat or Steam Sterilization

[B030EZO303815130]

Moist Heat or Steam Sterilization

[B030EZO303815130]

Moist Heat or Steam Sterilization

[B030EZO303815130]

Moist Heat or Steam Sterilization

[B030EZO303815130]

Moist Heat or Steam Sterilization

[B030EZO303815130]

Moist Heat or Steam Sterilization

[B030EZO303815130]

Moist Heat or Steam Sterilization

[B030EZO303815130]

Moist Heat or Steam Sterilization

[B030EZO303815130]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-07-24
• Device Publish Date: 2024-07-16

On-Brand Devices [Enza-O]

• B030EZO263215130: ENZA®-O 26mm x 32mm, 15° Lordotic, 13mm
• B030EZO303815170: ENZA®-O 30mm x 38mm, 15° Lordotic, 17mm
• B030EZO303815150: ENZA®-O 30mm x 38mm, 15° Lordotic, 15mm
• B030EZO303815130: ENZA®-O 30mm x 38mm, 15° Lordotic, 13mm
• B030EZO303815110: ENZA®-O 30mm x 38mm, 15° Lordotic, 11mm
• B030EZO303808170: ENZA®-O 30mm x 38mm, 8° Lordotic, 17mm
• B030EZO303808150: ENZA®-O 30mm x 38mm, 8° Lordotic, 15mm
• B030EZO303808130: ENZA®-O 30mm x 38mm, 8° Lordotic, 13mm
• B030EZO303808110: ENZA®-O 30mm x 38mm, 8° Lordotic, 11mm
• B030EZO303808090: ENZA®-O 30mm x 38mm, 8° Lordotic, 9mm
• B030EZO263215170: ENZA®-O 26mm x 32mm, 15° Lordotic, 17mm
• B030EZO263215150: ENZA®-O 26mm x 32mm, 15° Lordotic, 15mm
• B030EZO263215110: ENZA®-O 26mm x 32mm, 15° Lordotic, 11mm
• B030EZO263208170: ENZA®-O 26mm x 32mm, 8° Lordotic, 17mm
• B030EZO263208150: ENZA®-O 26mm x 32mm, 8° Lordotic, 15mm
• B030EZO263208130: ENZA®-O 26mm x 32mm, 8° Lordotic, 13mm
• B030EZO263208110: ENZA®-O 26mm x 32mm, 8° Lordotic, 11mm
• B030EZO263208090: ENZA®-O 26mm x 32mm, 8° Lordotic, 9mm
• B030EZO1020030: ENZA®-O Trial 26mm x 32mm, 8° Lordotic, 13mm
• B030EZO1020020: ENZA®-O Trial 26mm x 32mm, 8° Lordotic, 11mm
• B030EZO1020010: ENZA®-O Trial 26mm x 32mm, 8° Lordotic, 9mm
• B030EZO500002020: Instrument Tray 2
• B030EZO500002010: Instrument Tray 1
• B030EZO1020140: ENZA®-O Trial 30mm x 38mm, 8° Lordotic, 17mm
• B030EZO1020130: ENZA®-O Trial 30mm x 38mm, 8° Lordotic, 15mm
• B030EZO1020120: ENZA®-O Trial 30mm x 38mm, 8° Lordotic, 13mm
• B030EZO1020110: ENZA®-O Trial 30mm x 38mm, 8° Lordotic, 11mm
• B030EZO1020100: ENZA®-O Trial 30mm x 38mm, 8° Lordotic, 9mm
• B030EZO1020090: ENZA®-O Trial 26mm x 32mm, 15° Lordotic, 17mm
• B030EZO1020080: ENZA®-O Trial 26mm x 32mm, 15° Lordotic, 15mm
• B030EZO1020070: ENZA®-O Trial 26mm x 32mm, 15° Lordotic, 13mm
• B030EZO1020060: ENZA®-O Trial 26mm x 32mm, 15° Lordotic, 11mm
• B030EZO1020050: ENZA®-O Trial 26mm x 32mm, 8° Lordotic, 17mm
• B030EZO1020040: ENZA®-O Trial 26mm x 32mm, 8° Lordotic, 15mm