Data / Medical devices / United States / Nutech Spine, Inc.
Nutech Spine, Inc.: FDA-registered device maker in Birmingham, AL, United States, 2 510(k) clearances
Nutech Spine, Inc. is registered with the FDA (registration 3009169996) in Birmingham, AL, United States. It lists 5 device types. The FDA files 2 510(k) clearances under its listings, the newest dated September 14, 2009. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009169996
- Address
- 2231 20th Avenue South, Birmingham, AL, United States, 35223
- Owner or operator
- NuTech Spine, Inc. (10036081)
- Roles
- Complaint file establishment, Repackager or relabeler, Specification developer
- First device listed
- April 18, 2011
- Registered through
- 2026
- Brand names listed
- DuALIF, NuFix, NuTech, NuTech Biologics, NuTech Spine, NuTech Spine Pedicle Screw Spinal System, NuTech Spine Simplicity Plate, SIFix
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Appliance, Fixation, Spinal Interlaminal | KWP | 2 | Repackager or relabeler | accessdata.fda.gov |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | 2 | Repackager or relabeler | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Orthosis, Spinal Pedicle Fixation | MNI | 2 | Repackager or relabeler | accessdata.fda.gov |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | 2 | Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| September 14, 2009 | K092128 | MODIFICATION TO: PSS SYSTEM | MNI | Substantially Equivalent | Spinal USA | accessdata.fda.gov |
| April 18, 2006 | K060025 | SLIMPLICITY ANTERIOR CERVICAL PLATE SYSTEM | KWQ | Substantially Equivalent | Spinal USA | accessdata.fda.gov |
Compare with other makers
- All makers of Orthopedic Manual Surgical Instrument
- All makers of Orthosis, Spinal Pedicle Fixation
- All makers of Appliance, Fixation, Spinal Interlaminal
- All makers of Orthosis, Spondylolisthesis Spinal Fixation
- All makers of Appliance, Fixation, Spinal Intervertebral Body
Updated September 14, 2009. 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.