FDA product code PHM: Intervertebral Fusion Device With Bone Graft, Thoracic
PHM is the FDA product code for intervertebral fusion device with bone graft, thoracic. It is a Class II device, regulated under 21 CFR 888.3080 and reviewed by the Orthopedic panel. FDA has cleared 3 510(k) submissions under PHM, from 3 different applicants. The average 510(k) review took 105 days (median 97).
Definition
Intended to stabilize thoracic spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.
Classification
| Field | Value |
|---|---|
| Device name | Intervertebral Fusion Device With Bone Graft, Thoracic |
| Device class | Class II |
| Regulation | 21 CFR 888.3080 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for PHM
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 97 |
Compare with all 510(k) review times · Search every PHM clearance
Top PHM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Alphatec Spine, Inc. | 1 | 2018-05-31 |
| Alphatec Spine | 1 | 2016-09-08 |
| Nu Vasive, Incorporated | 1 | 2015-06-17 |
Most recent PHM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K180480 | Alphatec Spine, Inc. | ATEC Universal Spacer System | 2018-05-31 | 97 |
| K160958 | Alphatec Spine | Battalion Universal Spacer System | 2016-09-08 | 156 |
| K150994 | Nu Vasive, Incorporated | NuVasive CoRoent Thoracolumbar Implants | 2015-06-17 | 63 |
Recalls for PHM devices
openFDA lists no recalls for product code PHM.
Frequently asked questions
What is FDA product code PHM?
PHM is the FDA product code for intervertebral fusion device with bone graft, thoracic. It is a Class II device, regulated under 21 CFR 888.3080 and reviewed by the Orthopedic panel.
What device class is PHM?
Class II, regulation 21 CFR 888.3080. Typical premarket route: 510(k).
How long does a 510(k) take for product code PHM?
Across 3 cleared submissions the average was 105 days from receipt to decision (median 97).
Which companies have the most PHM clearances?
Alphatec Spine, Inc. (1); Alphatec Spine (1); Nu Vasive, Incorporated (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PHM
- Run a recall and safety report across every PHM manufacturer
- Watch product code PHM for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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