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TOBY ORTHOPAEDICS

Last updated September 17, 2026

Information

Country: US
Address: 6355 SW 8th Street, Suite 101, Miami, FL, 33144
Website: tobyortho.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 305-665-8699
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3008747271
DUNS Number: 024163331

Catalogue (155)

Page 2 of 4

Device	Model / Reference	Registries	Class	Status
WOLF Plate, 226mm, 17 Hole	NA	FDA UDI	Class II	Active
3.5mm T10 Drive Cortical Screw, 34mm	NA	FDA UDI	Class II	Active
3.5mm Cortical Screw, 32mm	NA	FDA UDI	Class II	Active
2.5mm Locking Screw Drill Guide, 45mm	NA	FDA UDI	Class I	Active
Precision Square Driver	NA	FDA UDI	Class I	Active
WOLF 3.5mm Screw Caddy	NA	FDA UDI	Class I	Active
2.7mm T10 Drive Bypass Cortical Locking Screw, 32mm	NA	FDA UDI	Class II	Active
Cross Element Guide	NA	FDA UDI	Class I	Active
5.2mm Post, 45mm	NA	FDA UDI	Class II	Active
3.5mm T10 Drive Cortical Screw, 20mm	NA	FDA UDI	Class II	Active
5.2mm Post, 50mm	NA	FDA UDI	Class II	Active
3.5mm T10 Drive Cortical Screw, 12mm	NA	FDA UDI	Class II	Active
3.5mm T10 Drive Cortical Locking Screw, 30mm	NA	FDA UDI	Class II	Active
2.0mm Drill Bit X 160mm	NA	FDA UDI	Class I	Active
Cross Element Guide Sleeve	NA	FDA UDI	Class I	Active
WOLF 3.5mm Low Profile Screw Caddy	NA	FDA UDI	Class I	Active
3.5mm Cortical Locking Screw, 30mm	NA	FDA UDI	Class II	Active
1.6mm K-Wire X 130mm	NA	FDA UDI	Class I	Active
2.5mm Drill Bit X 110mm	NA	FDA UDI	Class I	Active
Square Driver	NA	FDA UDI	Class I	Active
2.7mm T10 Drive Cortical Locking Screw, 28mm	NA	FDA UDI	Class II	Active
2.5mm Hex Driver	NA	FDA UDI	Class I	Active
2.7mm T10 Drive Cortical Locking Screw, 18mm	NA	FDA UDI	Class II	Active
WOLF Low Profile Plate, 70mm, 5 Hole	NA	FDA UDI	Class II	Active
3.5mm T10 Drive Cortical Screw, 14mm	NA	FDA UDI	Class II	Active
1.6mm K-Wire x 230mm	NA	FDA UDI	Class I	Active
3.5mm T10 Drive Cortical Locking Screw, 10mm	NA	FDA UDI	Class II	Active
2.7mm T10 Drive Bypass Cortical Locking Screw, 28mm	NA	FDA UDI	Class II	Active
PANTERA PLATE, RIGHT, 180mm	NA	FDA UDI	Class II	Active
PANTERA PLATE, LEFT, 73mm	NA	FDA UDI	Class II	Active
2.7mm T10 Drive Cortical Locking Screw, 10mm	NA	FDA UDI	Class II	Active
3.5mm Cortical Screw, 26mm	NA	FDA UDI	Class II	Active
3.5mm T10 Drive Cortical Locking Screw, 14mm	NA	FDA UDI	Class II	Active
WOLF Plate, 200mm, 15 Hole	NA	FDA UDI	Class II	Active
Pantera Screw Caddy	NA	FDA UDI	Class I	Active
Cross Element Guide Retainer	NA	FDA UDI	Class I	Active
2.7mm T10 Drive Cortical Locking Screw, 32mm	NA	FDA UDI	Class II	Active
2.7mm T10 Drive Cortical Locking Screw, 24mm	NA	FDA UDI	Class II	Active
3.5mm Cortical Locking Screw, 40mm	NA	FDA UDI	Class II	Active
3.5mm Cortical Screw, 20mm	NA	FDA UDI	Class II	Active
WOLF 2.7mm Low Profile Screw Caddy	NA	FDA UDI	Class I	Active
4.0mm Drill Bit X 110mm	NA	FDA UDI	Class I	Active
5.2mm Cannulated Post, 40mm	NA	FDA UDI	Class II	Active
PANTERA PLATE, RIGHT, 160mm	NA	FDA UDI	Class II	Active
4.0mm Cannulated Drill Bit X 130mm	NA	FDA UDI	Class I	Active
Post Drill Guide, 28mm	NA	FDA UDI	Class I	Active
Post Drill Guide Sleeve, 28mm	NA	FDA UDI	Class I	Active
2.0mm Cross Element, 25mm	NA	FDA UDI	Class II	Active
3.5mm T10 Drive Cortical Locking Screw, 35mm	NA	FDA UDI	Class II	Active
PANTERA PLATE, LEFT, 83mm	NA	FDA UDI	Class II	Active

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FDA Recalls (1)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Jun 5, 2013	Z-0599-2020	—	terminated	Potential suture clip breaking during a humerus fixation surgery.