FDA.reportPublic FDA data

S-Core™

Primary DI
10850017962290
Brand
S-Core™
Company
SUBCHONDRAL SOLUTIONS, INC.
Model
40-0500-01
Catalog number
40-0500-01
Device description
HA Coated 5 mm x 7.5 mm S-Core™ Implant W/Delivery system (00850017962156 and 00850017962224)
Published
2020-11-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
10850017962290PackageGS110In Commercial Distribution
00850017962293PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085001796229010850017962290
00850017962293008500179622938500179622930850017962293

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height5Millimeter
Length7.5Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
117417828
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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