Intervertebral Fusion Device With Bone Graft, Thoracic
The Intervertebral Fusion Device with Bone Graft for Thoracic Use is an orthopedic implant intended to stabilize thoracic spinal segments, promote spinal fusion, restrict motion, and decrease pain using bone graft material. It is an FDA Class 2 device regulated under 21 CFR 888.3080, requiring 510(k) premarket notification, within the Orthopedic (OR) medical specialty. The product code is PHM, and it is flagged as an implant due to its surgical placement between vertebrae. This device is not life-sustaining.
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Basic Information
- Product Code
- PHM
- Device Class
- FDA class 2
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Review Panel
- OR
- Submission Type
- 1
Device Characteristics
Definition
Intended to stabilize thoracic spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K180480 | ATEC Universal Spacer System | May 31, 2018 | Substantially Equivalent | Alphatec Spine, Inc. |
| K160958 | Battalion Universal Spacer System | Sep 08, 2016 | Substantially Equivalent | Alphatec Spine |
| K150994 | NuVasive CoRoent Thoracolumbar Implants | Jun 17, 2015 | Substantially Equivalent | Nu Vasive, Incorporated |
FEI Numbers
This FDA classification entry is associated with 76 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 76 registration numbers. Click on an entry to view related FDA registrations.