tobyortho.comWOLF LONG BONE PLATE SYSTEM
TOBY ORTHOPAEDICS
TOBY ORTHOPAEDICS
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3008747271 | 3008747271 | TOBY ORTHOPAEDICS | 1 | N | 2026-01-01 | 6355 SW 8th Street, Suite 101 Miami FL US 33144 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00816101011933 | WOLF Plate, 70mm, 5 Hole - The long bone plates are made of titanium alloy, are provided in standard and low profile thicknesses, and also standard and curved configurations. The plates are contoured to provide a close fit with the anatomy of the radius, ulna and humerus bones. The plates are provided with multiple hole configurations and lengths to accommodate fixation cases for a variety of upper extremity diaphyses. | 305-665-8699 | sales@tobyortho.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 99844 | 1656997799 | K131834 | WOLF LONG BONE PLATE SYSTEM | HRS | 2013-11-04 |
| 99844 | 1361604299 | K081608 | PROXIMAL HUMERUS SCAFFOLD FIXATION SYSTEM (PHSFS) | HRS | 2008-12-19 |
| 99844 | 1006014741 | ||||
| 99844 | 1046114390 | ||||
| 99844 | 1125086073 | ||||
| 99844 | 1185145965 | ||||
| 99844 | 1293291369 | ||||
| 99844 | 1346084437 | ||||
| 99844 | 1386126780 | ||||
| 99844 | 1696179578 | ||||
| 99844 | 1778195336 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| HRS | 2 | 2013-11-04 |
PMN#
PROXIMAL HUMERUS SCAFFOLD FIXATION SYSTEM (PHSFS)
TOBY ORTHOPAEDICS, LLC
GUDID#
Flexor Tendon Sheath Retractor and Suture Retriever / Sheath Dilator - The Flexor Tendon Sheath Retractor and Suture Retriever/ Sheath Dilator device, also referred to as the FTRT device, includes a sheath dilator tool and a transparent funnel-sheath retractor tool, that are to be used in surgical procedures that aim to repair lacerated digital flexor tendons.
2026-04-22
Cannulated Cruciform Driver with Quick Connect - Cannulated cruciform driver with quick-connect interface intended for manual insertion and removal of compatible orthopaedic screws
2026-04-21
WOLF Plate, 70mm, 5 Hole - The long bone plates are made of titanium alloy, are provided in standard and low profile thicknesses, and also standard and curved configurations. The plates are contoured to provide a close fit with the anatomy of the radius, ulna and humerus bones. The plates are provided with multiple hole configurations and lengths to accommodate fixation cases for a variety of upper extremity diaphyses.
2020-08-15
WOLF Plate, 96mm, 7 Hole - The long bone plates are made of titanium alloy, are provided in standard and low profile thicknesses, and also standard and curved configurations. The plates are contoured to provide a close fit with the anatomy of the radius, ulna and humerus bones. The plates are provided with multiple hole configurations and lengths to accommodate fixation cases for a variety of upper extremity diaphyses.
2020-08-15
WOLF Plate, 122mm, 9 Hole - The long bone plates are made of titanium alloy, are provided in standard and low profile thicknesses, and also standard and curved configurations. The plates are contoured to provide a close fit with the anatomy of the radius, ulna and humerus bones. The plates are provided with multiple hole configurations and lengths to accommodate fixation cases for a variety of upper extremity diaphyses.
2020-08-15
WOLF Plate, 148mm, 11 Hole - The long bone plates are made of titanium alloy, are provided in standard and low profile thicknesses, and also standard and curved configurations. The plates are contoured to provide a close fit with the anatomy of the radius, ulna and humerus bones. The plates are provided with multiple hole configurations and lengths to accommodate fixation cases for a variety of upper extremity diaphyses.
2020-08-15
WOLF Plate, 174mm, 13 Hole - The long bone plates are made of titanium alloy, are provided in standard and low profile thicknesses, and also standard and curved configurations. The plates are contoured to provide a close fit with the anatomy of the radius, ulna and humerus bones. The plates are provided with multiple hole configurations and lengths to accommodate fixation cases for a variety of upper extremity diaphyse
2020-08-15
WOLF Plate, 200mm, 15 Hole - The long bone plates are made of titanium alloy, are provided in standard and low profile thicknesses, and also standard and curved configurations. The plates are contoured to provide a close fit with the anatomy of the radius, ulna and humerus bones. The plates are provided with multiple hole configurations and lengths to accommodate fixation cases for a variety of upper extremity diaphyses.
2020-08-15
WOLF Plate, 226mm, 17 Hole - The long bone plates are made of titanium alloy, are provided in standard and low profile thicknesses, and also standard and curved configurations. The plates are contoured to provide a close fit with the anatomy of the radius, ulna and humerus bones. The plates are provided with multiple hole configurations and lengths to accommodate fixation cases for a variety of upper extremity diaphyses.
2020-08-15
WOLF Plate, 252mm, 19 Hole - The long bone plates are made of titanium alloy, are provided in standard and low profile thicknesses, and also standard and curved configurations. The plates are contoured to provide a close fit with the anatomy of the radius, ulna and humerus bones. The plates are provided with multiple hole configurations and lengths to accommodate fixation cases for a variety of upper extremity diaphyses.
2020-08-15
WOLF Plate, 278mm, 21 Hole - The long bone plates are made of titanium alloy, are provided in standard and low profile thicknesses, and also standard and curved configurations. The plates are contoured to provide a close fit with the anatomy of the radius, ulna and humerus bones. The plates are provided with multiple hole configurations and lengths to accommodate fixation cases for a variety of upper extremity diaphyses.
2020-08-15
WOLF Low Profile Plate, 70mm, 5 Hole - The long bone plates are made of titanium alloy, are provided in standard and low profile thicknesses, and also standard and curved configurations. The plates are contoured to provide a close fit with the anatomy of the radius, ulna and humerus bones. The plates are provided with multiple hole configurations and lengths to accommodate fixation cases for a variety of upper extremity diaphyses.
2020-08-15
WOLF Low Profile Plate, 96mm, 7 Hole - The long bone plates are made of titanium alloy, are provided in standard and low profile thicknesses, and also standard and curved configurations. The plates are contoured to provide a close fit with the anatomy of the radius, ulna and humerus bones. The plates are provided with multiple hole configurations and lengths to accommodate fixation cases for a variety of upper extremity diaphyses.
2020-08-15
WOLF Low Profile Plate, 122mm, 9 Hole - The long bone plates are made of titanium alloy, are provided in standard and low profile thicknesses, and also standard and curved configurations. The plates are contoured to provide a close fit with the anatomy of the radius, ulna and humerus bones. The plates are provided with multiple hole configurations and lengths to accommodate fixation cases for a variety of upper extremity diaphyses.
2020-08-15
WOLF Low Profile Plate, 148mm, 11 Hole - The long bone plates are made of titanium alloy, are provided in standard and low profile thicknesses, and also standard and curved configurations. The plates are contoured to provide a close fit with the anatomy of the radius, ulna and humerus bones. The plates are provided with multiple hole configurations and lengths to accommodate fixation cases for a variety of upper extremity diaphyses.
2020-08-15
WOLF Curved Low Profile Plate, 174mm, 13 Hole - The long bone plates are made of titanium alloy, are provided in standard and low profile thicknesses, and also standard and curved configurations. The plates are contoured to provide a close fit with the anatomy of the radius, ulna and humerus bones. The plates are provided with multiple hole configurations and lengths to accommodate fixation cases for a variety of upper extremity diaphyses.
2020-08-15
WOLF Curved Low Profile Plate, 200mm, 15 Hole - The long bone plates are made of titanium alloy, are provided in standard and low profile thicknesses, and also standard and curved configurations. The plates are contoured to provide a close fit with the anatomy of the radius, ulna and humerus bones. The plates are provided with multiple hole configurations and lengths to accommodate fixation cases for a variety of upper extremity diaphyses.
2020-08-15
WOLF Curved Low Profile Plate, 226mm, 17 Hole - The long bone plates are made of titanium alloy, are provided in standard and low profile thicknesses, and also standard and curved configurations. The plates are contoured to provide a close fit with the anatomy of the radius, ulna and humerus bones. The plates are provided with multiple hole configurations and lengths to accommodate fixation cases for a variety of upper extremity diaphyses.
2020-08-15
PANTERA PLATE, LEFT, 73mm - The shoulder plates are made of titanium alloy and are designed in right and left configurations, as well as various length configurations. The plates are contoured to provide a close fit with the anatomy of the proximal humerus. The distal segment of the plate is provided with between 4 (73mm configuration) and 13 (220mm configuration) holes to accommodate 3.5mm diameter locking or non-locking cortical screws. The proximal segment of the plate has 2 locking screw holes and 3 locking post holes. Around the proximal end are also 4 suture clips
2020-08-13
PANTERA PLATE, RIGHT, 73mm - The shoulder plates are made of titanium alloy and are designed in right and left configurations, as well as various length configurations. The plates are contoured to provide a close fit with the anatomy of the proximal humerus. The distal segment of the plate is provided with between 4 (73mm configuration) and 13 (220mm configuration) holes to accommodate 3.5mm diameter locking or non-locking cortical screws. The proximal segment of the plate has 2 locking screw holes and 3 locking post holes. Around the proximal end are also 4 suture clip.
2020-08-13
PANTERA PLATE, LEFT, 83mm - The shoulder plates are made of titanium alloy and are designed in right and left configurations, as well as various length configurations. The plates are contoured to provide a close fit with the anatomy of the proximal humerus. The distal segment of the plate is provided with between 4 (73mm configuration) and 13 (220mm configuration) holes to accommodate 3.5mm diameter locking or non-locking cortical screws. The proximal segment of the plate has 2 locking screw holes and 3 locking post holes. Around the proximal end are also 4 suture clips.
2020-08-13
PANTERA PLATE, RIGHT, 83mm - The shoulder plates are made of titanium alloy and are designed in right and left configurations, as well as various length configurations. The plates are contoured to provide a close fit with the anatomy of the proximal humerus. The distal segment of the plate is provided with between 4 (73mm configuration) and 13 (220mm configuration) holes to accommodate 3.5mm diameter locking or non-locking cortical screws. The proximal segment of the plate has 2 locking screw holes and 3 locking post holes. Around the proximal end are also 4 suture clips.
2020-08-13
PANTERA PLATE, RIGHT, 160mm - The shoulder plates are made of titanium alloy and are designed in right and left configurations, as well as various length configurations. The plates are contoured to provide a close fit with the anatomy of the proximal humerus. The distal segment of the plate is provided with between 4 (73mm configuration) and 13 (220mm configuration) holes to accommodate 3.5mm diameter locking or non-locking cortical screws. The proximal segment of the plate has 2 locking screw holes and 3 locking post holes. Around the proximal end are also 4 suture clips.
2020-08-13
PANTERA PLATE, LEFT, 160mm - The shoulder plates are made of titanium alloy and are designed in right and left configurations, as well as various length configurations. The plates are contoured to provide a close fit with the anatomy of the proximal humerus. The distal segment of the plate is provided with between 4 (73mm configuration) and 13 (220mm configuration) holes to accommodate 3.5mm diameter locking or non-locking cortical screws. The proximal segment of the plate has 2 locking screw holes and 3 locking post holes. Around the proximal end are also 4 suture clips.
2020-08-13
PANTERA PLATE, RIGHT, 180mm - The shoulder plates are made of titanium alloy and are designed in right and left configurations, as well as various length configurations. The plates are contoured to provide a close fit with the anatomy of the proximal humerus. The distal segment of the plate is provided with between 4 (73mm configuration) and 13 (220mm configuration) holes to accommodate 3.5mm diameter locking or non-locking cortical screws. The proximal segment of the plate has 2 locking screw holes and 3 locking post holes. Around the proximal end are also 4 suture clips.
2020-08-13
PANTERA PLATE, LEFT, 180mm - The shoulder plates are made of titanium alloy and are designed in right and left configurations, as well as various length configurations. The plates are contoured to provide a close fit with the anatomy of the proximal humerus. The distal segment of the plate is provided with between 4 (73mm configuration) and 13 (220mm configuration) holes to accommodate 3.5mm diameter locking or non-locking cortical screws. The proximal segment of the plate has 2 locking screw holes and 3 locking post holes. Around the proximal end are also 4 suture clips.
2020-08-13
PANTERA PLATE, RIGHT, 220mm - The shoulder plates are made of titanium alloy and are designed in right and left configurations, as well as various length configurations. The plates are contoured to provide a close fit with the anatomy of the proximal humerus. The distal segment of the plate is provided with between 4 (73mm configuration) and 13 (220mm configuration) holes to accommodate 3.5mm diameter locking or non-locking cortical screws. The proximal segment of the plate has 2 locking screw holes and 3 locking post holes. Around the proximal end are also 4 suture clips.
2020-08-13
PANTERA PLATE, LEFT, 220mm - The shoulder plates are made of titanium alloy and are designed in right and left configurations, as well as various length configurations. The plates are contoured to provide a close fit with the anatomy of the proximal humerus. The distal segment of the plate is provided with between 4 (73mm configuration) and 13 (220mm configuration) holes to accommodate 3.5mm diameter locking or non-locking cortical screws. The proximal segment of the plate has 2 locking screw holes and 3 locking post holes. Around the proximal end are also 4 suture clips.
2020-08-13
PANTERA PLATE, LEFT, 120mm - The shoulder plates are made of titanium alloy and are designed in right and left configurations, as well as various length configurations. The plates are contoured to provide a close fit with the anatomy of the proximal humerus. The distal segment of the plate is provided with between 4 (73mm configuration) and 13 (220mm configuration) holes to accommodate 3.5mm diameter locking or non-locking cortical screws. The proximal segment of the plate has 2 locking screw holes and 3 locking post holes. Around the proximal end are also 4 suture clips.
2020-08-13
PANTERA PLATE, RIGHT, 120mm - The shoulder plates are made of titanium alloy and are designed in right and left configurations, as well as various length configurations. The plates are contoured to provide a close fit with the anatomy of the proximal humerus. The distal segment of the plate is provided with between 4 (73mm configuration) and 13 (220mm configuration) holes to accommodate 3.5mm diameter locking or non-locking cortical screws. The proximal segment of the plate has 2 locking screw holes and 3 locking post holes. Around the proximal end are also 4 suture clips.
2020-08-13
5.2mm Cannulated Post, 40mm - Titanium alloy posts are used to affix the proximal end of the plate to the proximal end of the humerus. With the aid of fixtures, the posts have the ability to have cross elements inserted perpendicular to the axis of the cortical thread of the post. The head of the post is a threaded locking configuration that accepts an expansion cap screw. The posts are 5.25mm in diameter and are available in 5 lengths ranging from 30mm to 50mm. They are cannulated i.e a K-wire can pass through the post longitudinally.
2020-08-07
5.2mm Cannulated Post, 30mm - Titanium alloy posts are used to affix the proximal end of the plate to the proximal end of the humerus. With the aid of fixtures, the posts have the ability to have cross elements inserted perpendicular to the axis of the cortical thread of the post. The head of the post is a threaded locking configuration that accepts an expansion cap screw. The posts are 5.25mm in diameter and are available in 5 lengths ranging from 30mm to 50mm. They are cannulated i.e a K-wire can pass through the post longitudinally.
2020-08-07
2.7mm T10 Drive Cortical Locking Screw, 10mm - The titanium alloy cortical locking screws (torx T-10 head) are used to affix the plate to the bone. The screws are 2.7mm in diameter and are available in various lengths from 10mm to 34mm.
2020-08-17
2.7mm T10 Drive Cortical Locking Screw, 12mm - The titanium alloy cortical locking screws (torx T-10 head) are used to affix the plate to the bone. The screws are 2.7mm in diameter and are available in various lengths from 10mm to 34mm.
2020-08-17
2.7mm T10 Drive Cortical Locking Screw, 14mm - The titanium alloy cortical locking screws (torx T-10 head) are used to affix the plate to the bone. The screws are 2.7mm in diameter and are available in various lengths from 10mm to 34mm.
2020-08-17
2.7mm T10 Drive Cortical Locking Screw, 16mm - The titanium alloy cortical locking screws (torx T-10 head) are used to affix the plate to the bone. The screws are 2.7mm in diameter and are available in various lengths from 10mm to 34mm.
2020-08-17
2.7mm T10 Drive Cortical Locking Screw, 18mm - The titanium alloy cortical locking screws (torx T-10 head) are used to affix the plate to the bone. The screws are 2.7mm in diameter and are available in various lengths from 10mm to 34mm.
2020-08-17
2.7mm T10 Drive Cortical Locking Screw, 20mm - The titanium alloy cortical locking screws (torx T-10 head) are used to affix the plate to the bone. The screws are 2.7mm in diameter and are available in various lengths from 10mm to 34mm.
2020-08-17
2.7mm T10 Drive Cortical Locking Screw, 22mm - The titanium alloy cortical locking screws (torx T-10 head) are used to affix the plate to the bone. The screws are 2.7mm in diameter and are available in various lengths from 10mm to 34mm.
2020-08-17
2.7mm T10 Drive Cortical Locking Screw, 24mm - The titanium alloy cortical locking screws (torx T-10 head) are used to affix the plate to the bone. The screws are 2.7mm in diameter and are available in various lengths from 10mm to 34mm.
2020-08-17