Data / Medical devices / United States / Orthonovis, Inc.
Orthonovis, Inc.: FDA-registered device maker in Palm Coast, FL, United States, 14 510(k) clearances
Orthonovis, Inc. is registered with the FDA (registration 3015946784) in Palm Coast, FL, United States. It lists 12 device types. The FDA files 14 510(k) clearances under its listings, the newest dated October 2, 2025. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3015946784
- Address
- 1 Hargrove Grade Ste 4, Palm Coast, FL, United States, 32137
- Owner or operator
- OrthoNovis, Inc. (10061543)
- Roles
- Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- October 28, 2019
- Registered through
- 2027
- Brand names listed
- BPS Bone Fragment Fixation Plates, Screws and Washers, BPS Wrist Fracture System, BPSS Affinity Wrist Fracture System, BPSS Foot Plating System, BPSS Memory Metal Staple System, BTB Bone Graft Putty, CSM, Cannulated Screw and Kirschner (K wire) System and more
Devices it lists
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 2, 2025 | K252758 | Cannulated Screw and Kirschner (K wire) System | HWC | Substantially Equivalent | Orthonovis, Inc. | accessdata.fda.gov |
| March 17, 2025 | K250498 | BPS Wrist Fracture System | HRS | Substantially Equivalent | Orthonovis, Inc. | accessdata.fda.gov |
| February 6, 2025 | K250055 | BPS - Bone Fragment Fixation Plates, Screws and Washers | HRS | Substantially Equivalent | Orthonovis, Inc. | accessdata.fda.gov |
| October 4, 2024 | K242343 | BPS Wrist Fracture System | HRS | Substantially Equivalent | Orthonovis, Inc. | accessdata.fda.gov |
| August 25, 2022 | K213905 | ONX Large External Fixation System | KTT | Substantially Equivalent | Orthonovis, Inc. | accessdata.fda.gov |
| February 10, 2022 | K203811 | GPC Intraheal Intramedullary Nailing System | HSB | Substantially Equivalent | Gpc Medical Limited | accessdata.fda.gov |
| September 16, 2019 | K191641 | AFFINITY Variable Angle Distal Radius System, AFFINITY Variable Angle Distal Radius Plates, AFFINITY Variable Angle Distal Radius Screws | HRS | Substantially Equivalent | Industrias Medicas Sampedro S.A.S | accessdata.fda.gov |
| June 16, 2017 | K162674 | BioPro Foot Plating Systems | HRS | Substantially Equivalent | Biopro, Inc. | accessdata.fda.gov |
| February 2, 2016 | K153211 | M-Fix Acromioclavicular Device | HTN | Substantially Equivalent | Coracoid Solutions, Inc. | accessdata.fda.gov |
| January 22, 2014 | K130613 | CANNULATED SCREW AND KIRSCHNER (KWIRE) SYSTEM | HWC | Substantially Equivalent | Laura Cattabriga | accessdata.fda.gov |
| January 17, 2014 | K130614 | BONE FRAGMENT AND FIXATION PLATES, SCREWS AND WASHERS | HRS | Substantially Equivalent | Laura Cattabriga | accessdata.fda.gov |
| December 9, 2008 | K082672 | NOVABONE PUTTY-BIOACTIVE SYNTHETIC BONE GRAFT | MQV | Substantially Equivalent | Novabone Products, LLC | accessdata.fda.gov |
| August 21, 2006 | K061798 | BIOPRO MEMORY STAPLE | JDR | Substantially Equivalent | Biopro, Inc. | accessdata.fda.gov |
| October 24, 2001 | K012990 | COLLATEK POWDER | KGN | Substantially Equivalent | Biocore Medical Technologies, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Mixer, Blood Tube
- All makers of Filler, Bone Void, Calcium Compound
- All makers of Washer, Bolt Nut
- All makers of Screw, Fixation, Bone
- All makers of Plate, Fixation, Bone
- All makers of Wound Dressing With Animal-Derived Material(S)
Updated October 2, 2025. 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.