FDA.reportPublic FDA data

ToeTac™ Hammertoe Fixation System, Large

Primary DI
10815375021836
Brand
ToeTac™ Hammertoe Fixation System, Large
Company
Restore Surgical LLC
Model
HT-00003
Published
2015-10-17
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HWCScrew, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWCScrew, Fixation, BoneOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10815375021836PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081537502183610815375021836

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone pin, non-bioabsorbableA small diameter rod typically used for the fixation of a bone fracture or bone grafts, or for an osteotomy or arthrodesis. The rod may be smooth, wholly- or partially-threaded, solid or cannulated, and some designs may be tapered; it is not specific to the clavicle bone. The device is made of a material that is not chemically degraded or absorbed by natural body processes (e.g., implant grade metal, surgical steel, titanium alloy, or carbon fibre). Some designs may have a break-off shank and/or may be coated [e.g., with hydroxyapatite, also known as hydroxylapatite (HA)] to improve purchase in osteoporotic bone and for long-term fixation. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
792932626
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10815375021058CMC Cable FixCM90002015-10-17
10815375021812ToeTac™ Hammertoe Fixation System, SmallHT-000012015-10-17
10815375021829ToeTac™ Hammertoe Fixation System, MediumHT-00002 2015-10-17
10815375021065Sub-Talar LokST50072015-10-17
10815375021072Sub-Talar LokST50082015-10-17
10815375021089Sub-Talar LokST50092015-10-17
10815375021096Sub-Talar LokST50102015-10-17
10815375021102Sub-Talar LokST50112015-10-17
10815375020013Mini Cannulated Titanium Headed and Headless Screw SetIC25102015-10-17
10815375020020Mini Cannulated Titanium Headed and Headless Screw SetIC25122015-10-17
10815375020037Mini Cannulated Titanium Headed and Headless Screw SetIC25142015-10-17
10815375020044Mini Cannulated Titanium Headed and Headless Screw SetIC25162015-10-17
10815375020051Mini Cannulated Titanium Headed and Headless Screw SetIC25182015-10-17
10815375020068Mini Cannulated Titanium Headed and Headless Screw SetIC25202015-10-17
10815375020075Mini Cannulated Titanium Headed and Headless Screw SetIC25222015-10-17
10815375020082Mini Cannulated Titanium Headed and Headless Screw SetIC25242015-10-17
10815375020099Mini Cannulated Titanium Headed and Headless Screw SetIC25262015-10-17
10815375020105Mini Cannulated Titanium Headed and Headless Screw SetIC25282015-10-17
10815375020112Mini Cannulated Titanium Headed and Headless Screw SetIC25302015-10-17
10815375020129Mini Cannulated Titanium Headed and Headless Screw SetIC25322015-10-17

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Primary DI, Brand, Company table
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00842078100035HammerFiXEXTREMITY MEDICAL, LLCHWC2026-10-29
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