PHM
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Intervertebral Fusion Device With Bone Graft, Thoracic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3080
- Medical specialty
- Orthopedic
- Flags
- Implant
- FDA definition
- Intended to stabilize thoracic spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.
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| Record | Firm | Date |
|---|---|---|
| ATEC Universal Spacer System (K180480) | Alphatec Spine, Inc. | 2018-05-31 |
| Battalion Universal Spacer System (K160958) | Alphatec Spine | 2016-09-08 |
| NuVasive CoRoent Thoracolumbar Implants (K150994) | Nu Vasive, Incorporated | 2015-06-17 |
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