neoWave C N/A

GUDID 00818345027312

neoWave C Cervical Cage, 13W x 12D x 10H, 0 deg

HT MEDICAL, LLC

Metallic spinal interbody fusion cage

• Primary Device ID: 00818345027312
• NIH Device Record Key: 744ce09b-bcc9-4b3c-afa1-8742108f36fb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: neoWave C
• Version Model Number: 20-CFN-3210
• Catalog Number: N/A
• Company DUNS: 080386764
• Company Name: HT MEDICAL, 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: true
• 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: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00818345027312 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180401

FDA Product Code

• ODP: Intervertebral Fusion Device With Bone Graft, Cervical

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-04-08
• Device Publish Date: 2022-03-31

On-Brand Devices [neoWave C]

• 00818345027657: neoWave C Cervical Cage, 19W x 14D x 12H, 0 deg
• 00818345027640: neoWave C Cervical Cage, 19W x 14D x 11H, 0 deg
• 00818345027633: neoWave C Cervical Cage, 19W x 14D x 10H, 0 deg
• 00818345027626: neoWave C Cervical Cage, 19W x 14D x 9H, 0 deg
• 00818345027619: neoWave C Cervical Cage, 19W x 14D x 8H, 0 deg
• 00818345027602: neoWave C Cervical Cage, 19W x 14D x 7H, 0 deg
• 00818345027596: neoWave C Cervical Cage, 19W x 14D x 6H, 0 deg
• 00818345027589: neoWave C Cervical Cage, 19W x 14D x 5H, 0 deg
• 00818345027572: neoWave C Cervical Cage, 17W x 13D x 12H, 0 deg
• 00818345027565: neoWave C Cervical Cage, 17W x 13D x 11H, 0 deg
• 00818345027558: neoWave C Cervical Cage, 17W x 13D x 10H, 0 deg
• 00818345027541: neoWave C Cervical Cage, 17W x 13D x 9H, 0 deg
• 00818345027534: neoWave C Cervical Cage, 17W x 13D x 8H, 0 deg
• 00818345027527: neoWave C Cervical Cage, 17W x 13D x 7H, 0 deg
• 00818345027510: neoWave C Cervical Cage, 17W x 13D x 6H, 0 deg
• 00818345027503: neoWave C Cervical Cage, 17W x 13D x 5H, 0 deg
• 00818345027497: neoWave C Cervical Cage, 16W x 14D x 12H, 0 deg
• 00818345027480: neoWave C Cervical Cage, 16W x 14D x 11H, 0 deg
• 00818345027473: neoWave C Cervical Cage, 16W x 14D x 10H, 0 deg
• 00818345027466: neoWave C Cervical Cage, 16W x 14D x 9H, 0 deg
• 00818345027459: neoWave C Cervical Cage, 16W x 14D x 8H, 0 deg
• 00818345027442: neoWave C Cervical Cage, 16W x 14D x 7H, 0 deg
• 00818345027435: neoWave C Cervical Cage, 16W x 14D x 6H, 0 deg
• 00818345027428: neoWave C Cervical Cage, 16W x 14D x 5H, 0 deg
• 00818345027411: neoWave C Cervical Cage, 15W x 12D x 12H, 0 deg
• 00818345027404: neoWave C Cervical Cage, 15W x 12D x 11H, 0 deg
• 00818345027398: neoWave C Cervical Cage, 15W x 12D x 10H, 0 deg
• 00818345027381: neoWave C Cervical Cage, 15W x 12D x 9H, 0 deg
• 00818345027374: neoWave C Cervical Cage, 15W x 12D x 8H, 0 deg
• 00818345027367: neoWave C Cervical Cage, 15W x 12D x 7H, 0 deg
• 00818345027350: neoWave C Cervical Cage, 15W x 12D x 6H, 0 deg
• 00818345027343: neoWave C Cervical Cage, 15W x 12D x 5H, 0 deg
• 00818345027336: neoWave C Cervical Cage, 13W x 12D x 12H, 0 deg
• 00818345027329: neoWave C Cervical Cage, 13W x 12D x 11H, 0 deg
• 00818345027312: neoWave C Cervical Cage, 13W x 12D x 10H, 0 deg
• 00818345027305: neoWave C Cervical Cage, 13W x 12D x 9H, 0 deg
• 00818345027299: neoWave C Cervical Cage, 13W x 12D x 8H, 0 deg
• 00818345027282: neoWave C Cervical Cage, 13W x 12D x 7H, 0 deg
• 00818345027275: neoWave C Cervical Cage, 13W x 12D x 6H, 0 deg
• 00818345027268: neoWave C Cervical Cage, 13W x 12D x 5H, 0 deg
• 00818345026506: neoWave C Cervical Cage, 19W x 14D x 12H, 14 deg
• 00818345026490: neoWave C Cervical Cage, 19W x 14D x 11H, 14 deg
• 00818345026483: neoWave C Cervical Cage, 19W x 14D x 10H, 14 deg
• 00818345026476: neoWave C Cervical Cage, 19W x 14D x 9H, 14 deg
• 00818345026469: neoWave C Cervical Cage, 19W x 14D x 8H, 14 deg
• 00818345026452: neoWave C Cervical Cage, 19W x 14D x 7H, 14 deg
• 00818345026445: neoWave C Cervical Cage, 19W x 14D x 6H, 14 deg
• 00818345026438: neoWave C Cervical Cage, 19W x 14D x 5H, 14 deg
• 00818345026421: neoWave C Cervical Cage, 17W x 13D x 12H, 14 deg
• 00818345026414: neoWave C Cervical Cage, 17W x 13D x 11H, 14 deg