FDA.reportPublic FDA data

S-Core™

Primary DI
00850017962392
Brand
S-Core™
Company
SUBCHONDRAL SOLUTIONS, INC.
Model
10-1165
Catalog number
10-1165
Device description
Size 6 Cannulated Sizer
Published
2022-05-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
00850017962392PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850017962392008500179623928500179623920850017962392

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw, non-bioabsorbable, sterileA small, 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). There are a number of kinds available: 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 across bone fragments.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
117417828
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850017962002S-Core™20-0400-P20-0400-P2020-11-15
00850017962019S-Core™20-0500-P20-0500-P2020-11-15
00850017962026S-Core™20-0600-P2020-11-15
00850017962033S-Core™20-0700-P20-0700-P2020-11-15
00850017962040S-Core™20-0800-P20-0800-P2020-11-15
00850017962057S-Core™20-0900-P20-0900-P2020-11-15
00850017962064S-Core™20-1000-P20-1000-P2020-11-15
00850017962071S-Core™10-2004-P10-2004-P2020-11-19
00850017962088S-Core™10-2005-P10-2005-P2020-11-19
00850017962095S-Core™10-2006-P10-2006-P2020-11-19
00850017962101S-Core™10-2007-P10-2007-P2020-11-19
00850017962118S-Core™10-2008-P10-2008-P2020-11-19
00850017962125S-Core™10-2009-P10-2009-P2020-11-19
00850017962132S-Core™10-2010-P10-2010-P2020-11-19
00850017962149S-Core™20-0400-01-P20-0400-01-P2020-10-22
00850017962156S-Core™20-0500-01-P20-0500-01-P2020-10-22
00850017962163S-Core™20-0600-01-P20-0600-01-P2020-10-22
00850017962170S-Core™20-0700-01-P20-0700-01-P2020-10-22
00850017962187S-Core™20-0800-01-P20-0800-01-P2020-10-22
00850017962194S-Core™20-0900-01-P20-0900-01-P2020-10-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00885556904879EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556904923EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906163EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906170EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906187EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906194EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906200EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906217EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906224EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906231EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906248EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906255EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906262EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906279EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906286EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906293EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906309EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906316EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906323EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556901946EVOSSmith & Nephew, Inc.HWC2026-06-24
00193982586393CAPTIVATEGLOBUS MEDICAL, INC.HWC2026-06-10
00193982586416CAPTIVATEGLOBUS MEDICAL, INC.HWC2026-06-10
00193982586430CAPTIVATEGLOBUS MEDICAL, INC.HWC2026-06-10
00193982586454CAPTIVATEGLOBUS MEDICAL, INC.HWC2026-06-10
00193982586478CAPTIVATEGLOBUS MEDICAL, INC.HWC2026-06-10
00193982586690CAPTIVATEGLOBUS MEDICAL, INC.HWC2026-06-10
00193982586706CAPTIVATEGLOBUS MEDICAL, INC.HWC2026-06-10
00193982586713CAPTIVATEGLOBUS MEDICAL, INC.HWC2026-06-10
00193982586720CAPTIVATEGLOBUS MEDICAL, INC.HWC2026-06-10
00193982586737CAPTIVATEGLOBUS MEDICAL, INC.HWC2026-06-10