Data / Medical devices / United States / Toby Orthopaedics
Toby Orthopaedics: FDA-registered device maker in Miami, FL, United States, 2 510(k) clearances
Toby Orthopaedics is registered with the FDA (registration 3008747271) in Miami, FL, United States. It lists 11 device types. The FDA files 2 510(k) clearances under its listings, the newest dated November 4, 2013. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008747271
- Address
- 6355 SW 8th Street, Suite 101, Miami, FL, United States, 33144
- Owner or operator
- Toby Orthopaedics (10028539)
- Roles
- Manufacturer
- First device listed
- February 10, 2009
- Registered through
- 2026
- Brand names listed
- Flexor Tendon Sheath Retractor, Flexor Tendon Suture Retriever/ Sheath Dilator, PANTERA®- Proximal Humerus Fracture Fixation Plate System, TOBY- Depth Gauge, TOBY- Drill Bits, TOBY- Drivers, TOBY- SURGICAL RETAINER, TOBY- Sterilization Tray and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bit, Drill | HTW | 1 | Manufacturer | accessdata.fda.gov |
| Gauge, Depth | HTJ | 1 | Manufacturer | accessdata.fda.gov |
| Guide, Surgical, Instrument | FZX | 1 | Manufacturer | accessdata.fda.gov |
| Passer | HWQ | 1 | Manufacturer | accessdata.fda.gov |
| Plate, Fixation, Bone | HRS | 2 | Manufacturer | accessdata.fda.gov |
| Retainer, Surgical | GCZ | 1 | Manufacturer | accessdata.fda.gov |
| Retractor | GAD | 1 | Manufacturer | accessdata.fda.gov |
| Screw, Fixation, Bone | HWC | 2 | Manufacturer | accessdata.fda.gov |
| Screwdriver | HXX | 1 | Manufacturer | accessdata.fda.gov |
| Tray, Surgical | LRP | 1 | Manufacturer | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | 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 |
|---|---|---|---|---|---|---|
| November 4, 2013 | K131834 | WOLF LONG BONE PLATE SYSTEM | HRS | Substantially Equivalent | Toby Orthopaedics | accessdata.fda.gov |
| December 19, 2008 | K081608 | PROXIMAL HUMERUS SCAFFOLD FIXATION SYSTEM (PHSFS) | HRS | Substantially Equivalent | Toby Orthopaedics, LLC | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| June 5, 2013 | 83963 | Class II | Terminated | PANTERA Proximal Humerus Fracture Plate System | Potential suture clip breaking during a humerus fixation surgery. | accessdata.fda.gov |
Compare with other makers
- All makers of Retractor
- All makers of Plate, Fixation, Bone
- All makers of Passer
- All makers of Guide, Surgical, Instrument
- All makers of Screw, Fixation, Bone
- All makers of Screwdriver
Updated November 4, 2013. 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.