Toby Orthopaedics

Miami, FL, US

TOBY ORTHOPAEDICS appears in FDA device records in Miami, FL. FDA records list 2 510(k) clearances between 2008-12-19 and 2013-11-04, no PMA records and one registered establishment. As of 2026-09-10, FDA records show one recall for this company, and at least one establishment registration is current.

510(k) clearances: 2
PMA records: 0
Recall records: 1
Registered establishments: 1

510(k) clearance history

FDA records hold 2 510(k) clearances for Toby Orthopaedics between 2008 and 2013. The busiest year on record is 2008, with 1. The most recent is 2013, with 1.

Clearances by year, as a table

510(k) clearance decisions for Toby Orthopaedics, by decision year
Year	Clearances
2008	1
2013	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K131834	WOLF LONG BONE PLATE SYSTEM	HRS	Substantially Equivalent	2013-11-04
K081608	PROXIMAL HUMERUS SCAFFOLD FIXATION SYSTEM (PHSFS)	HRS	Substantially Equivalent	2008-12-19

Registered establishments

FDA registered establishments for Toby Orthopaedics, with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
3008747271	3008747271	TOBY ORTHOPAEDICS	6355 SW 8th Street, Suite 101, Miami, FL 33144 US	2026	FSM FZX GAD GCZ HRS HTJ HTW HWC HWQ HXX and 1 more, listed in full below

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-0599-2020	PANTERA Proximal Humerus Fracture Plate System	Potential suture clip breaking during a humerus fixation surgery.	Class II	2013-06-05	Terminated

Verification record

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain