S-Core™ 20-0900-P

GUDID 10850017962054

9 mm x 9.5 mm S-Core Implant

SUBCHONDRAL SOLUTIONS, INC.

Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile
Primary Device ID10850017962054
NIH Device Record Keye5108cd9-fd5d-461c-b069-bde5fc5e1958
Commercial Distribution StatusIn Commercial Distribution
Brand NameS-Core™
Version Model Number20-0900-P
Catalog Number20-0900-P
Company DUNS117417828
Company NameSUBCHONDRAL SOLUTIONS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Height9 Millimeter
Length9.5 Millimeter
Height9 Millimeter
Length9.5 Millimeter
Height9 Millimeter
Length9.5 Millimeter
Height9 Millimeter
Length9.5 Millimeter
Height9 Millimeter
Length9.5 Millimeter
Height9 Millimeter
Length9.5 Millimeter
Height9 Millimeter
Length9.5 Millimeter
Height9 Millimeter
Length9.5 Millimeter
Height9 Millimeter
Length9.5 Millimeter
Height9 Millimeter
Length9.5 Millimeter
Height9 Millimeter
Length9.5 Millimeter
Height9 Millimeter
Length9.5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100850017962057 [Primary]
GS110850017962054 [Package]
Contains: 00850017962057
Package: Case [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2022-05-09
Device Publish Date2020-11-15

On-Brand Devices [S-Core™]

10850017962344HA Coated 10 mm x 10 mm S-Core™ Implant W/Delivery system (00850017962200 and 00850017962279)
10850017962337HA Coated 9 mm x 9.5 mm S-Core™ Implant W/Delivery system (00850017962194 and 00850017962262)
00850017962323HA Coated 8 mm x 9 mm S-Core™ Implant W/Delivery system (00850017962187 and 00850017962255)
10850017962313HA Coated 7 mm x 8.5 mm S-Core™ Implant W/Delivery system (00850017962170 and 00850017962248)
10850017962306HA Coated 6 mm x 8 mm S-Core™ Implant W/Delivery system (00850017962163 and 00850017962231)
10850017962290HA Coated 5 mm x 7.5 mm S-Core™ Implant W/Delivery system (00850017962156 and 00850017962224)
10850017962283HA Coated 4 mm x 7 mm S-Core™ Implant W/Delivery system (00850017962149 and 00850017962217)
1085001796227610 mm x 8 mm Cannulated Drill and 10 mm Countersink (00850017962576 and 00850017962613)
108500179622699 mm x 7.5 mm Cannulated Drill and 9 mm Countersink (00850017962569 and 00850017962507)
008500179622558 mm x 7 mm Cannulated Drill and 8 mm Countersink (00850017962552 and 00850017962491)
108500179622457 mm x 6.5 mm Cannulated Drill and 7 mm Countersink (00850017962545 and 00850017962484)
108500179622386 mm x 6 mm Cannulated Drill and 6 mm Countersink (00850017962538 and 00850017962477)
108500179622215 mm x 5.5 mm Cannulated Drill and 5 mm Countersink (00850017962521 and 00850017962460)
108500179622144 mm x 5mm Cannulated Drill and 4 mm Countersink (00850017962514 and 00850017962453)
1085001796213910 mm x 8 mm Cannulated Drill and 10 mm Countersink, Non-Sterile
108500179621229 mm x 7.5 mm Cannulated Drill and 9 mm Countersink, Non-Sterile
108500179621158 mm x 7 mm Cannulated Drill and 8 mm Countersink, Non-Sterile
108500179621087 mm x 6.5 mm Cannulated Drill and 7 mm Countersink, Non-Sterile
108500179620926 mm x 6 mm Cannulated Drill and 6 mm Countersink, Non-Sterile
108500179620855 mm x 5.5 mm Cannulated Drill and 5 mm Countersink, Non-Sterile
108500179620784 mm x 5 mm Cannulated Drill and 4 mm Countersink, Non-Sterile
1085001796206110 mm x 10 mm S-Core Implant
108500179620549 mm x 9.5 mm S-Core Implant
108500179620478 mm x 9 mm S-Core Implant
108500179620307 mm x 8.5 mm S-Core Implant
108500179620236 mm x 8 mm S-Core Implant
108500179620165 mm x 7.5 mm S-Core Implant
108500179620094 mm x 7 mm S-Core Implant
0085001796261310mm x 8mm Drill
0085001796260610mm x 14mm Drill, Long
10850017962597HA Coated 10 mm x 14 mm S-Core™ Implant W/Delivery system (00850017962583 and 00850017962439)
1085001796258010 mm x 14 mm Cannulated Drill Long and 10 mm Countersink (00850017962606 and 00850017962576)
008500179625699mm Countersink
008500179625528mm Countersink
008500179625456mm Countersink
008500179625386mm Countersink
008500179625215mm Countersink
008500179625144mm Countersink
008500179625079mm x 7.5mm Drill
008500179624918mm x 7mm Drill
008500179624776mm x 6mm Drill
008500179624605mm x 5.5mm Drill
008500179624534mm x 5mm Drill
00850017962446Cannulated Sizer Set (00850017962354, 00850017962361, 00850017962378, 00850017962385, 0085001796
10850017962436HA Coated 10 mm x 14 mm S-Core™ Implant
00850017962422T10 Torque Driver
00850017962415Size 4 Cannulated Sizer
00850017962408Size 5 Cannulated Sizer
00850017962392Size 6 Cannulated Sizer
00850017962385Size 7 Cannulated Sizer

Trademark Results [S-Core]

Mark Image

Registration | Serial
Company
Trademark
Application Date
S-CORE
S-CORE
88900220 not registered Live/Pending
SUBCHONDRAL SOLUTIONS INC
2020-05-04
S-CORE
S-CORE
73084842 1053940 Dead/Cancelled
Weyerhaeuser Company
1976-04-23

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