Data / Medical devices / United States / P&F Machining
P&F Machining: FDA-registered device maker in Otsego, MN, United States, 1 510(k) clearance
P&F Machining is registered with the FDA (registration 3015860552) in Otsego, MN, United States. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated February 25, 2014. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3015860552
- Address
- 8450 Quaday Ave NE, Otsego, MN, United States, 55330
- Owner or operator
- P&F Machining (10061255)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- October 3, 2019
- Registered through
- 2027
- Brand names listed
- Presson Spinal Fixation System, Smith and Nephew, Trauma Plate System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | 2 | Contract manufacturer | accessdata.fda.gov |
| Instrument, Manual, Surgical, General Use | MDM | 1 | Manufacturer | accessdata.fda.gov |
| Orthosis, Spinal Pedicle Fixation | MNI | 2 | Manufacturer | accessdata.fda.gov |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | 2 | 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 |
|---|---|---|---|---|---|---|
| February 25, 2014 | K133287 | PRESSON SPINAL FIXATION SYSTEM | MNH | Substantially Equivalent | Nexus Spine, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Appliance, Fixation, Spinal Intervertebral Body
- All makers of Instrument, Manual, Surgical, General Use
- All makers of Orthosis, Spondylolisthesis Spinal Fixation
- All makers of Orthosis, Spinal Pedicle Fixation
Updated February 25, 2014. 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.