Data / Medical devices / United States / Avanti Orthopaedics LLC
Avanti Orthopaedics LLC: FDA-registered device maker in Penn Valley, PA, United States, 3 510(k) clearances
Avanti Orthopaedics LLC is registered with the FDA (registration 3016247852) in Penn Valley, PA, United States. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated November 23, 2022. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3016247852
- Address
- 1245 Hollow Road, Penn Valley, PA, United States, 19072
- Owner or operator
- Avanti (10062225)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- December 30, 2019
- Registered through
- 2026
- Brand names listed
- Avanti Cannulated Screw, Avanti Distal Radius Plates, Avanti Forearm Plates, Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Compression Screws, Avanti Orthopaedics 3.2mm, and 4mm Cannulated Compression Screws, Avanti Orthopaedics Ulnar Shortening System, Avanti Ulnar Plates, Avanti Wrist Fusion Plates and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Plate, Fixation, Bone | HRS | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Screw, Fixation, Bone | HWC | 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 |
|---|---|---|---|---|---|---|
| November 23, 2022 | K222967 | Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and 4.0mm Cannulated Screws | HWC | Substantially Equivalent | Avanti Orthopaedics, Inc. | accessdata.fda.gov |
| July 16, 2021 | K211592 | Avanti Orthopaedics Ulnar Shortening System | HRS | Substantially Equivalent | Avanti Orthopaedics, Inc. | accessdata.fda.gov |
| December 13, 2019 | K191118 | Avanti Distal Radius and Forearm System | HRS | Substantially Equivalent | Avanti Orthopaedics, Inc. | accessdata.fda.gov |
Compare with other makers
Updated November 23, 2022. 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.