FDA product code PHQ: Anterior Staple As Supplemental Fixation For Fusion
PHQ is the FDA product code for anterior staple as supplemental fixation for fusion. It is a Class II device, regulated under 21 CFR 888.3060 and reviewed by the Orthopedic panel. FDA has cleared 2 510(k) submissions under PHQ, from 2 different applicants. The average 510(k) review took 288 days (median 288).
Definition
Anterior cervical device for supplemental fixation to support a fusion.
Classification
| Field | Value |
|---|---|
| Device name | Anterior Staple As Supplemental Fixation For Fusion |
| Device class | Class II |
| Regulation | 21 CFR 888.3060 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for PHQ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2021 | 1 | 363 |
Compare with all 510(k) review times · Search every PHQ clearance
Top PHQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Pressio, Inc. | 1 | 2021-02-03 |
| Medicrea International | 1 | 2014-07-24 |
Most recent PHQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K200301 | Pressio, Inc. | UNiTi ACDF Implant System | 2021-02-03 | 363 |
| K133906 | Medicrea International | C-JAWS CERVICAL COMPRESSIVE STAPLE | 2014-07-24 | 213 |
Recalls for PHQ devices
openFDA lists no recalls for product code PHQ.
Frequently asked questions
What is FDA product code PHQ?
PHQ is the FDA product code for anterior staple as supplemental fixation for fusion. It is a Class II device, regulated under 21 CFR 888.3060 and reviewed by the Orthopedic panel.
What device class is PHQ?
Class II, regulation 21 CFR 888.3060. Typical premarket route: 510(k).
How long does a 510(k) take for product code PHQ?
Across 2 cleared submissions the average was 288 days from receipt to decision (median 288).
Which companies have the most PHQ clearances?
Pressio, Inc. (1); Medicrea International (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PHQ
- Run a recall and safety report across every PHQ manufacturer
- Watch product code PHQ 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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