FDA.reportPublic FDA data

Mini Cannulated Titanium Headed and Headless Screw Set

Primary DI
10815375020068
Brand
Mini Cannulated Titanium Headed and Headless Screw Set
Company
Restore Surgical LLC
Model
IC2520
Published
2015-10-17
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
10815375020068PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081537502006810815375020068

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw, non-bioabsorbable, non-sterileA small, non-sterile, threaded rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that cannot be chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). Screws available are: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded, self-tapping, and cannulated. A "lag screw" can be any of these used to obtain compression. This device must be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
792932626
Device count
1
Lot or batch
true
Sterilization required before use
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
10815375021836ToeTac™ Hammertoe Fixation System, LargeHT-00003 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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00196449002511LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002528LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002535LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002542LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002559LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002566LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002573LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002580LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002597LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002603LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002610LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002627LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002634LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002641LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002658LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002665LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002672LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002689LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002696LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002702LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002719LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002726LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002733LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002740LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002757LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002764LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002771LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002788LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002795LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002801LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08