SPIRA™-C Open Matrix Cervical Interbody

GUDID B030SPC1214507110

12mm x 14.5mm, 7° Lordotic, 11mm

CAMBER SPINE TECHNOLOGIES, LLC

Metallic spinal fusion cage, non-sterile

• Primary Device ID: B030SPC1214507110
• NIH Device Record Key: fd7f6492-53a0-449a-8887-de8015bbecab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SPIRA™-C Open Matrix Cervical Interbody
• Version Model Number: SPC-12145-0711
• 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 Identifiers

Device Issuing Agency	Device ID
HIBCC	B030SPC1214507110 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172446

FDA Product Code

• ODP: Intervertebral Fusion Device With Bone Graft, Cervical

Sterilization

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

[B030SPC1214507110]

Moist Heat or Steam Sterilization

[B030SPC1214507110]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-05
• Device Publish Date: 2018-02-17

On-Brand Devices [SPIRA™-C Open Matrix Cervical Interbody]

• B030SPC1251607120: 12.5mm x 16mm, 7° Lordotic, 12mm
• B030SPC1251607110: 12.5mm x 16mm, 7° Lordotic, 11mm
• B030SPC1251607100: 12.5mm x 16mm, 7° Lordotic, 10mm
• B030SPC1251607090: 12.5mm x 16mm, 7° Lordotic, 9mm
• B030SPC1251607080: 12.5mm x 16mm, 7° Lordotic, 8mm
• B030SPC1251607070: 12.5mm x 16mm, 7° Lordotic, 7mm
• B030SPC1251607060: 12.5mm x 16mm, 7° Lordotic, 6mm
• B030SPC1251607050: 12.5mm x 16mm, 7° Lordotic, 5mm
• B030SPC1214507120: 12mm x 14.5mm, 7° Lordotic, 12mm
• B030SPC1214507110: 12mm x 14.5mm, 7° Lordotic, 11mm
• B030SPC1214507100: 12mm x 14.5mm, 7° Lordotic, 10mm
• B030SPC1214507090: 12mm x 14.5mm, 7° Lordotic, 9mm
• B030SPC1214507080: 12mm x 14.5mm, 7° Lordotic, 8mm
• B030SPC1214507070: 12mm x 14.5mm, 7° Lordotic, 7mm
• B030SPC1214507060: 12mm x 14.5mm, 7° Lordotic, 6mm
• B030SPC1214507050: 12mm x 14.5mm, 7° Lordotic, 5mm
• B030SPC0131807120: 13mm x 18mm, 7° Lordotic, 12mm
• B030SPC0131807110: 13mm x 18mm, 7° Lordotic, 11mm
• B030SPC0131807100: 13mm x 18mm, 7° Lordotic, 10mm
• B030SPC0131807090: 13mm x 18mm, 7° Lordotic, 9mm
• B030SPC0131807080: 13mm x 18mm, 7° Lordotic, 8mm
• B030SPC0131807070: 13mm x 18mm, 7° Lordotic, 7mm
• B030SPC0131807060: 13mm x 18mm, 7° Lordotic, 6mm
• B030SPC0131807050: 13mm x 18mm, 7° Lordotic, 5mm
• B030SPC151807100: 15mm x 18mm, 7° Lordotic, 10mm
• B030SPC151807090: 15mm x 18mm, 7° Lordotic, 9mm
• B030SPC151807080: 15mm x 18mm, 7° Lordotic, 8mm
• B030SPC151807070: 15mm x 18mm, 7° Lordotic, 7mm
• B030SPC151807060: 15mm x 18mm, 7° Lordotic, 6mm
• B030SPC141607120: 14mm x 16mm, 7° Lordotic, 12mm
• B030SPC141607110: 14mm x 16mm, 7° Lordotic, 11mm
• B030SPC141607100: 14mm x 16mm, 7° Lordotic, 10mm
• B030SPC141607090: 14mm x 16mm, 7° Lordotic, 9mm
• B030SPC141607080: 14mm x 16mm, 7° Lordotic, 8mm
• B030SPC141607070: 14mm x 16mm, 7° Lordotic, 7mm
• B030SPC141607060: 14mm x 16mm, 7° Lordotic, 6mm
• B030SPC141607050: 14mm x 16mm, 7° Lordotic, 5mm
• B030SPC1314AN120: 13mm x 14mm, Anatomic, 12mm
• B030SPC1314AN110: 13mm x 14mm, Anatomic, 11mm
• B030SPC1314AN100: 13mm x 14mm, Anatomic, 10mm
• B030SPC1314AN090: 13mm x 14mm, Anatomic, 9mm
• B030SPC1314AN080: 13mm x 14mm, Anatomic, 8mm
• B030SPC1314AN070: 13mm x 14mm, Anatomic, 7mm
• B030SPC1314AN060: 13mm x 14mm, Anatomic, 6mm
• B030SPC1314AN050: 13mm x 14mm, Anatomic, 5mm
• B030SPC131412120: 13mm x 14mm, 12° Lordotic, 12mm
• B030SPC131412110: 13mm x 14mm, 12° Lordotic, 11mm
• B030SPC131412100: 13mm x 14mm, 12° Lordotic, 10mm
• B030SPC131412090: 13mm x 14mm, 12° Lordotic, 9mm
• B030SPC131412080: 13mm x 14mm, 12° Lordotic, 8mm