SureMAX Family Of Cervical Spacers

Intervertebral Fusion Device With Bone Graft, Cervical

Additive Implants, Inc

The following data is part of a premarket notification filed by Additive Implants, Inc with the FDA for Suremax Family Of Cervical Spacers.

Pre-market Notification Details

• Device ID: K193359
• 510k Number: K193359
• Device Name: SureMAX Family Of Cervical Spacers
• Classification: Intervertebral Fusion Device With Bone Graft, Cervical
• Applicant: Additive Implants, Inc 3101 E. Shea Blvd, Suite 122 Phoenix, AZ 85028
• Contact: Jeff Horn
• Correspondent: Karen E. Warden; BackRoads Consulting 12520 Heath Road Chesterland, OH 44026
• Product Code: ODP
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-12-04
• Decision Date: 2020-01-03

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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