Data / Medical devices / Anterior Staple As Supplemental Fixation For Fusion
Anterior Staple As Supplemental Fixation For Fusion (PHQ): 6 FDA-registered makers in 3 countries
6 establishments in 3 countries are registered with the FDA to make Anterior Staple As Supplemental Fixation For Fusion (product code PHQ, Class 2, 21 CFR 888.3060). 1 of them has a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 2 510(k) clearances under this code, the latest on February 3, 2021, and lists 0 recall events (0 Class I). FDA data exported November 3, 2026.
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- Product code
- PHQ
- Device class
- 2
- Regulation
- 888.3060
- Medical specialty
- Orthopedic
- Implant
- Yes
Makers by country
| Country | Makers |
|---|---|
| Malaysia | 3 |
| United States | 2 |
| Germany | 1 |
Makers of Anterior Staple As Supplemental Fixation For Fusion
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Pressio, Inc. | San Antonio, TX, United States | Complaint file establishment, Specification developer | 1 | February 3, 2021 | 0 | 0 | 0 | api.fda.gov |
| Blaze Biotech, LLC | San Antonio, TX, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| HG Medical GmbH | Raisting Bavaria, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Straits Orthopaedics (MFG) Sdn Bhd | Simpang Ampat Pulau Pinang, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Straits Orthopaedics (MFG) Sdn Bhd | Perai Pulau Pinang, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Straits Orthopaedics (MFG) Sdn Bhd | Bandar Cassia Pulau Pinang, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated February 3, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.