CHENA-C PEEK Spacer System

GUDID B644CCS1515513070

CHENA-C PEEK Spacer 5 Deg 15.5 x 13 x 7mm

AXIS360 SURGICAL, INCOPORATED

Vertebral body prosthesis, non-sterile

• Primary Device ID: B644CCS1515513070
• NIH Device Record Key: 6984f366-152c-4d37-a5b2-dd7f7111b1f4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CHENA-C PEEK Spacer System
• Version Model Number: CCS1-5-15513-07
• Company DUNS: 081208474
• Company Name: AXIS360 SURGICAL, INCOPORATED
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B644CCS1515513070 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181140

FDA Product Code

• ODP: Intervertebral Fusion Device With Bone Graft, Cervical

Sterilization

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

[B644CCS1515513070]

Moist Heat or Steam Sterilization

[B644CCS1515513070]

Moist Heat or Steam Sterilization

[B644CCS1515513070]

Moist Heat or Steam Sterilization

[B644CCS1515513070]

Moist Heat or Steam Sterilization

[B644CCS1515513070]

Moist Heat or Steam Sterilization

[B644CCS1515513070]

Moist Heat or Steam Sterilization

[B644CCS1515513070]

Moist Heat or Steam Sterilization

[B644CCS1515513070]

Moist Heat or Steam Sterilization

[B644CCS1515513070]

Moist Heat or Steam Sterilization

[B644CCS1515513070]

Moist Heat or Steam Sterilization

[B644CCS1515513070]

Moist Heat or Steam Sterilization

[B644CCS1515513070]

Moist Heat or Steam Sterilization

[B644CCS1515513070]

Moist Heat or Steam Sterilization

[B644CCS1515513070]

Moist Heat or Steam Sterilization

[B644CCS1515513070]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-07-17
• Device Publish Date: 2018-12-31

On-Brand Devices [CHENA-C PEEK Spacer System]

• B644CCS1517515100: CHENA-C PEEK Spacer 5 Deg 17.5 x 15 x 10mm
• B644CCS1517515090: CHENA-C PEEK Spacer 5 Deg 17.5 x 15 x 9mm
• B644CCS1517515080: CHENA-C PEEK Spacer 5 Deg 17.5 x 15 x 8mm
• B644CCS1517515070: CHENA-C PEEK Spacer 5 Deg 17.5 x 15 x 7mm
• B644CCS1517515060: CHENA-C PEEK Spacer 5 Deg 17.5 x 15 x 6mm
• B644CCS1517515050: CHENA-C PEEK Spacer 5 Deg 17.5 x 15 x 5mm
• B644CCS1515513100: CHENA-C PEEK Spacer 5 Deg 15.5 x 13 x 10mm
• B644CCS1515513090: CHENA-C PEEK Spacer 5 Deg 15.5 x 13 x 9mm
• B644CCS1515513080: CHENA-C PEEK Spacer 5 Deg 15.5 x 13 x 8mm
• B644CCS1515513070: CHENA-C PEEK Spacer 5 Deg 15.5 x 13 x 7mm
• B644CCS1515513060: CHENA-C PEEK Spacer 5 Deg 15.5 x 13 x 6mm
• B644CCS1515513050: CHENA-C PEEK Spacer 5 Deg 15.5 x 13 x 5mm
• B644CCS1513511100: CHENA-C PEEK Spacer 5 Deg 13.5 x 11 x 10mm
• B644CCS1513511090: CHENA-C PEEK Spacer 5 Deg 13.5 x 11 x 9mm
• B644CCS1513511080: CHENA-C PEEK Spacer 5 Deg 13.5 x 11 x 8mm
• B644CCS1513511070: CHENA-C PEEK Spacer 5 Deg 13.5 x 11 x 7mm
• B644CCS1513511060: CHENA-C PEEK Spacer 5 Deg 13.5 x 11 x 6mm
• B644CCS1513511050: CHENA-C PEEK Spacer 5 Deg 13.5 x 11 x 5mm