S-Core Implant System
Subchondral Solutions, Inc.
SUBCHONDRAL SOLUTIONS
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3016660811 | 3016660811 | SUBCHONDRAL SOLUTIONS | 1 | N | 2026-01-01 | 1725 Monrovia Ave Suite C-5 Costa Mesa CA US 92627 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 239426 | 1145378527 | K220901 | S-Core Implant System | MBI | 2022-07-29 |
| 239426 | 1490387530 | K191995 | S4 Screw System | HWC | 2020-04-18 |
| 239426 | 1611550448 | K162171 | S4 Screw System™ | HWC | 2017-09-07 |
| 239426 | 2029565224 |
Product Codes Associated With Registrations#
PMN#
S4 Screw System
Subchondral Solutions, Inc.
S4 Screw System™
SUBCHONDRAL SOLUTIONS
GUDID#
S-Core™ - HA Coated 8 mm x 9 mm S-Core™ Implant W/Delivery system (00850017962187 and 00850017962255)
2020-11-15
S-Core™ - 8 mm x 7 mm Cannulated Drill and 8 mm Countersink (00850017962552 and 00850017962491)
2020-11-15
S-Core™ - 10mm x 8mm Drill
2022-05-06
S-Core™ - 10mm x 14mm Drill, Long
2022-05-06
S-Core™ - 9mm Countersink
2022-05-06
S-Core™ - 8mm Countersink
2022-05-06
S-Core™ - 6mm Countersink
2022-05-06
S-Core™ - 6mm Countersink
2022-05-06
S-Core™ - 5mm Countersink
2022-05-06
S-Core™ - 4mm Countersink
2022-05-06
S-Core™ - 9mm x 7.5mm Drill
2022-05-06
S-Core™ - 8mm x 7mm Drill
2022-05-06
S-Core™ - 6mm x 6mm Drill
2022-05-06
S-Core™ - 5mm x 5.5mm Drill
2022-05-06
S-Core™ - 4mm x 5mm Drill
2022-05-06
S-Core™ - Cannulated Sizer Set (00850017962354, 00850017962361, 00850017962378, 00850017962385, 00850017962392, 00850017962408, 00850017962415, 00850017962422, 008500179624239)
2022-05-06
S-Core™ - T10 Torque Driver
2022-05-06
S-Core™ - Size 4 Cannulated Sizer
2022-05-06
S-Core™ - Size 5 Cannulated Sizer
2022-05-06
S-Core™ - Size 6 Cannulated Sizer
2022-05-06
S-Core™ - Size 7 Cannulated Sizer
2022-05-06
S-Core™ - Size 8 Cannulated Sizer
2022-05-06
S-Core™ - Size 9 Cannulated Sizer
2022-05-06
S-Core™ - Size 10 Cannulated Sizer
2022-05-06
S-Core™ - 10mm Countersink
2023-03-06
S-Core™ - 7mm x 6.5mm drill
2023-03-06
S-Core™ - HA Coated 10 mm x 14 mm S-Core™ Implant W/Delivery system (00850017962583 and 00850017962439)
2022-05-06
S-Core™ - 10 mm x 14 mm Cannulated Drill Long and 10 mm Countersink (00850017962606 and 00850017962576)
2022-05-06
S-Core™ - HA Coated 10 mm x 14 mm S-Core™ Implant
2022-05-06
S-Core™ - HA Coated 10 mm x 10 mm S-Core™ Implant W/Delivery system (00850017962200 and 00850017962279)
2020-11-15
S-Core™ - HA Coated 9 mm x 9.5 mm S-Core™ Implant W/Delivery system (00850017962194 and 00850017962262)
2020-11-15
S-Core™ - HA Coated 7 mm x 8.5 mm S-Core™ Implant W/Delivery system (00850017962170 and 00850017962248)
2020-11-15
S-Core™ - HA Coated 6 mm x 8 mm S-Core™ Implant W/Delivery system (00850017962163 and 00850017962231)
2020-11-15
S-Core™ - HA Coated 5 mm x 7.5 mm S-Core™ Implant W/Delivery system (00850017962156 and 00850017962224)
2020-11-15
S-Core™ - HA Coated 4 mm x 7 mm S-Core™ Implant W/Delivery system (00850017962149 and 00850017962217)
2020-11-15
S-Core™ - 10 mm x 8 mm Cannulated Drill and 10 mm Countersink (00850017962576 and 00850017962613)
2020-11-15
S-Core™ - 9 mm x 7.5 mm Cannulated Drill and 9 mm Countersink (00850017962569 and 00850017962507)
2020-11-15
S-Core™ - 7 mm x 6.5 mm Cannulated Drill and 7 mm Countersink (00850017962545 and 00850017962484)
2020-11-15
S-Core™ - 6 mm x 6 mm Cannulated Drill and 6 mm Countersink (00850017962538 and 00850017962477)
2020-11-15
S-Core™ - 5 mm x 5.5 mm Cannulated Drill and 5 mm Countersink (00850017962521 and 00850017962460)
2020-11-15