FDA.reportPublic FDA data

S-Core™

Primary DI
00850017962637
Brand
S-Core™
Company
SUBCHONDRAL SOLUTIONS, INC.
Model
10-0708
Catalog number
10-0708
Device description
Sizer, 7mm/8mm
Published
2023-03-06
Public version status
New
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
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850017962637PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850017962637008500179626378500179626370850017962637

GMDN Terms#

Term, Definition table
TermDefinition
Surgical implant/trial-implant/sizer holder, single-useA hand-held manual surgical instrument designed to connect to and hold an implant (e.g., bone screw, bone graft), trial implant, or implantable device sizer/template (e.g., glenoid defect sizer, hearing implant template) to facilitate guidance, gauging/sizing, and/or monitoring of the held device during orthopaedic or ear/nose/throat (ENT) surgery. The instrument is typically made of metal or synthetic polymer materials and is typically constructed in the form of a long shaft with a handle at the proximal end and a device holding/fixation mechanism at the distal end. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Lumen/Inner Diameter7Millimeter
Lumen/Inner Diameter8Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
117417828
Device count
1
Premarket exempt
true
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
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
00840286860093Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.LXH2026-07-09
00840286860109Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.LXH2026-07-09
00840286860116Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.LXH2026-07-09
10705034647463N/AMedos International SàrlLXH2026-07-09
B382SD49400B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49401B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49402B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49403B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49404B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49405B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49406B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49407B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49408B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49409B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49410B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49411B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49412B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49413B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49414B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49415B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49416B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49417B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49418B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49419B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49420B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD500010Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD500020Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD500030Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD500040Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD500050Surgical DirectSurgical Direct, Inc.LXH2026-07-09