Data / Medical devices / United States / Summa Orthopaedics Inc.
Summa Orthopaedics Inc.: FDA-registered device maker in Berwyn, PA, United States, 1 510(k) clearance
Summa Orthopaedics Inc. is registered with the FDA (registration 3014522470) in Berwyn, PA, United States. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated May 30, 2014. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014522470
- Address
- 11 Woodside Ave, Berwyn, PA, United States, 19312
- Owner or operator
- Summa Orthopaedics (10057283)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- March 23, 2018
- Registered through
- 2026
- Brand names listed
- Optossol Compression Device System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Pin, Fixation, Threaded | JDW | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Screw, Fixation, Bone | HWC | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Washer, Bolt Nut | HTN | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| May 30, 2014 | K140875 | OPTOSSOL COMPRESSION DEVICE SYSTEM | JDW | Substantially Equivalent | Genossis, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Screw, Fixation, Bone
- All makers of Pin, Fixation, Threaded
- All makers of Washer, Bolt Nut
Updated May 30, 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.