Data / Medical devices / United States / Pro Surgical, Inc.
Pro Surgical, Inc.: FDA-registered device maker in Carlsbad, CA, United States, 3 510(k) clearances
Pro Surgical, Inc. is registered with the FDA (registration 3031081659) in Carlsbad, CA, United States. It lists 5 device types. The FDA files 3 510(k) clearances under its listings, the newest dated June 24, 2025. 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
- 3031081659
- Address
- 1910 Palomar Point Way, Suite 201, Carlsbad, CA, United States, 92008
- Owner or operator
- Pro Surgical, Inc. (10090745)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- May 8, 2024
- Registered through
- 2026
- Brand names listed
- Pro Surgical Orthopedic manual instruments, ProAM ALIF System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Complaint file establishment, Manufacturer | 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 |
|---|---|---|---|---|---|---|
| June 24, 2025 | K251644 | ProAM ALIF System | OVD | Substantially Equivalent | Pro Surgical, Inc. | accessdata.fda.gov |
| November 20, 2024 | K242517 | ProAM ACDF System | OVE | Substantially Equivalent | Pro Surgical, Inc. | accessdata.fda.gov |
| May 3, 2024 | K240126 | ProAM ALIF System | OVD | Substantially Equivalent | Pro Surgical, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Intervertebral Fusion Device With Integrated Fixation, Lumbar
- All makers of Intervertebral Fusion Device With Bone Graft, Lumbar
- All makers of Orthopedic Manual Surgical Instrument
- All makers of Intervertebral Fusion Device With Integrated Fixation, Cervical
- All makers of Intervertebral Fusion Device With Bone Graft, Cervical
Updated June 24, 2025. 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.