FDA.reportPublic FDA data

S-Core™

Primary DI
00850017962149
Brand
S-Core™
Company
SUBCHONDRAL SOLUTIONS, INC.
Model
20-0400-01-P
Catalog number
20-0400-01-P
Device description
HA Coated 4 mm x 7 mm S-Core Implant
Published
2020-10-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191995000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191995000S4 Screw SystemSubchondral Solutions, Inc.2020-04-18HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850017962146PackageGS110In Commercial Distribution
00850017962149PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085001796214610850017962146
00850017962149008500179621498500179621490850017962149

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height4Millimeter
Length7Millimeter

Regulatory Flags#

DUNS number
117417828
Device count
1
Lot or batch
true
Expiration date on label
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
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
00850017962200S-Core™20-1000-01-P20-1000-01-P2020-10-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810112592245TriLEAPSynthes GmbHHWC2024-02-23
00810112592252TriLEAPSynthes GmbHHWC2024-02-23
00810112592429TriLEAPSynthes GmbHHWC2024-02-23
00810112592450TriLEAPSynthes GmbHHWC2024-02-23
00810112592467TriLEAPSynthes GmbHHWC2024-02-23
00810112592474TriLEAPSynthes GmbHHWC2024-02-23
00810112592634TriLEAPSynthes GmbHHWC2024-02-23
00810112592832TriLEAPSynthes GmbHHWC2024-02-23
00810112592849TriLEAPSynthes GmbHHWC2024-02-23
00810112592986TriLEAPSynthes GmbHHWC2024-02-22
00810112592993TriLEAPSynthes GmbHHWC2024-02-22
00810112593006TriLEAPSynthes GmbHHWC2024-02-22
00810112593013TriLEAPSynthes GmbHHWC2024-02-22
00810112593020TriLEAPSynthes GmbHHWC2024-02-22
00810112593037TriLEAPSynthes GmbHHWC2024-02-22
00810112593044TriLEAPSynthes GmbHHWC2024-02-22
00810112593051TriLEAPSynthes GmbHHWC2024-02-22
00810112593068TriLEAPSynthes GmbHHWC2024-02-22
00810112593075TriLEAPSynthes GmbHHWC2024-02-22
00810112593082TriLEAPSynthes GmbHHWC2024-02-22
00810112593099TriLEAPSynthes GmbHHWC2024-02-22
00810112593105TriLEAPSynthes GmbHHWC2024-02-22
00810112593112TriLEAPSynthes GmbHHWC2024-02-22
00810112593129TriLEAPSynthes GmbHHWC2024-02-22
00810112593136TriLEAPSynthes GmbHHWC2024-02-22
00810112593143TriLEAPSynthes GmbHHWC2024-02-22
00810112593150TriLEAPSynthes GmbHHWC2024-02-22
00810112593167TriLEAPSynthes GmbHHWC2024-02-22
00810112593174TriLEAPSynthes GmbHHWC2024-02-22
00810112593181TriLEAPSynthes GmbHHWC2024-02-22