Contact Us

As we grow, our commitment to transforming care remains the same

We would love to hear from you:

 

3Spine SEZC
Cayman Enterprise City
The Strathvale House, 4th floor
90 N Church Street
George Town, Grand Cayman
Cayman Islands
1-345-232-069
3Spine Management Co. Inc
46 Railroad Ave
Unit 204
Duxbury, MA 02332
1-781-291-8040
clinical@balancedback.com

About 3Spine

3Spine is a new kind of healthcare company that vertically integrates the development, clinical research, and delivery of novel healthcare technology.  The BalancedBack Total Joint Replacement is the technology platform developed by 3Spine as an alternative to fusion for the lumbar spine.

3Spine SEZC

Cayman Enterprise City

The Strathvale House, 4th floor

90 N Church Street

George Town, Grand Cayman

Cayman Islands

1-345-232-0690

3Spine Management Co. Inc

46 Railroad Ave

Unit 204

Duxbury, MA 02332

1-781-291-8040

US Regulatory Status

CAUTION: Investigational Device. Limited by United States law to investigational use.

The BalancedBack Total Joint Replacement is not available in the United States. The information within BalancedBack.com
is not intended as a substitute for medical professional help or advice. Statements made on this site are not to be
interpreted as a guarantee.

Cayman REGULATORY STATUS

The BalancedBack Total Joint Replacement is undergoing clinical trial in the Cayman Islands in compliance with section 9
of the 2018 Health Practice Regulations.

South africa REGULATORY STATUS

The BalancedBack Total Joint Replacement is a Class D device in South Africa per Rule 8. This device is available for
investigational use only per Schedule 16 of the Department of Health Regulation No. 1515. The BalancedBack Total Joint
Replacement is for professional use only.

To learn more about Breakthrough Designation

https://www.fda.gov/regulatory-information/selected-amendments-fdc-act/21st-century-cures-act

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