Data / Medical devices / United States / Penn United Technologies, Inc.
Penn United Technologies, Inc.: FDA-registered device maker in Warminster, PA, United States, 1 510(k) clearance
Penn United Technologies, Inc. is registered with the FDA (registration 3008125983) in Warminster, PA, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated October 25, 2011. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008125983
- Address
- 1756 Stout Dr PO 2926, Warminster, PA, United States, 18974
- Owner or operator
- Penn United Technologies, Inc. (10044967)
- Roles
- Manufacturer
- First device listed
- September 3, 2013
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Arthroscope | HRX | 2 | Manufacturer | accessdata.fda.gov |
| Cement, Bone, Vertebroplasty | NDN | 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 |
|---|---|---|---|---|---|---|
| October 25, 2011 | K110998 | AFFIRM (TM) VCF SYSTEM | NDN | Substantially Equivalent | Algea Therapies | accessdata.fda.gov |
Compare with other makers
Updated October 25, 2011. 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.