Data / Medical devices / United States / Paramount Surgicals, Inc.
Paramount Surgicals, Inc.: FDA-registered device maker in Brownsville, TX, United States, 3 510(k) clearances
Paramount Surgicals, Inc. is registered with the FDA (registration 3006404019) in Brownsville, TX, United States. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated April 16, 2007. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3006404019
- FEI number
- 3003909293
- Address
- 3475 W Alton Gloor Blvd Ste B, Brownsville, TX, United States, 78520
- Owner or operator
- PARAMOUNT SURGICALS, INC. (9104801)
- Roles
- Repackager or relabeler, Specification developer
- First device listed
- July 23, 2007
- Registered through
- 2026
- Brand names listed
- RADIX CERVICAL PLATE, SIMPLEX CERVICAL PLATE, UNIMAX
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | 2 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Orthosis, Spinal Pedicle Fixation | MNI | 2 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | 2 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 16, 2007 | K070335 | SIMPLEX CERVICAL FIXATION SYSTEM | KWQ | Substantially Equivalent | Pisharodi Surgicals, Inc. | accessdata.fda.gov |
| July 1, 2004 | K033951 | RADIX CERVICAL PLATE | KWQ | Substantially Equivalent | Pisharodi Surgicals, Inc. | accessdata.fda.gov |
| March 29, 2002 | K014302 | UNIVERSAL MULTIAXIS (UNIMAX) PEDICLE SCREW SYSTEM | MNH | Substantially Equivalent | Pisharodi Surgicals, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Appliance, Fixation, Spinal Intervertebral Body
- All makers of Orthosis, Spondylolisthesis Spinal Fixation
- All makers of Orthosis, Spinal Pedicle Fixation
Updated April 16, 2007. 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.