S-Core™ 10-1050
GUDID 00850017962521
5mm Countersink
SUBCHONDRAL SOLUTIONS, INC.
Orthopaedic bone screw, non-bioabsorbable, sterile| Primary Device ID | 00850017962521 |
| NIH Device Record Key | e636338d-2038-4d38-8f54-ccc7f61863c1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | S-Core™ |
| Version Model Number | 10-1050 |
| Catalog Number | 10-1050 |
| Company DUNS | 117417828 |
| Company Name | SUBCHONDRAL SOLUTIONS, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Device Dimensions
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850017962521 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K162171
FDA Product Code
| HWC | Screw, Fixation, Bone |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-05-16 |
| Device Publish Date | 2022-05-06 |
On-Brand Devices [S-Core™]
| 10850017962344 | HA Coated 10 mm x 10 mm S-Core™ Implant W/Delivery system (00850017962200 and 00850017962279) |
| 10850017962337 | HA Coated 9 mm x 9.5 mm S-Core™ Implant W/Delivery system (00850017962194 and 00850017962262) |
| 00850017962323 | HA Coated 8 mm x 9 mm S-Core™ Implant W/Delivery system (00850017962187 and 00850017962255) |
| 10850017962313 | HA Coated 7 mm x 8.5 mm S-Core™ Implant W/Delivery system (00850017962170 and 00850017962248) |
| 10850017962306 | HA Coated 6 mm x 8 mm S-Core™ Implant W/Delivery system (00850017962163 and 00850017962231) |
| 10850017962290 | HA Coated 5 mm x 7.5 mm S-Core™ Implant W/Delivery system (00850017962156 and 00850017962224) |
| 10850017962283 | HA Coated 4 mm x 7 mm S-Core™ Implant W/Delivery system (00850017962149 and 00850017962217) |
| 10850017962276 | 10 mm x 8 mm Cannulated Drill and 10 mm Countersink (00850017962576 and 00850017962613) |
| 10850017962269 | 9 mm x 7.5 mm Cannulated Drill and 9 mm Countersink (00850017962569 and 00850017962507) |
| 00850017962255 | 8 mm x 7 mm Cannulated Drill and 8 mm Countersink (00850017962552 and 00850017962491) |
| 10850017962245 | 7 mm x 6.5 mm Cannulated Drill and 7 mm Countersink (00850017962545 and 00850017962484) |
| 10850017962238 | 6 mm x 6 mm Cannulated Drill and 6 mm Countersink (00850017962538 and 00850017962477) |
| 10850017962221 | 5 mm x 5.5 mm Cannulated Drill and 5 mm Countersink (00850017962521 and 00850017962460) |
| 10850017962214 | 4 mm x 5mm Cannulated Drill and 4 mm Countersink (00850017962514 and 00850017962453) |
| 10850017962139 | 10 mm x 8 mm Cannulated Drill and 10 mm Countersink, Non-Sterile |
| 10850017962122 | 9 mm x 7.5 mm Cannulated Drill and 9 mm Countersink, Non-Sterile |
| 10850017962115 | 8 mm x 7 mm Cannulated Drill and 8 mm Countersink, Non-Sterile |
| 10850017962108 | 7 mm x 6.5 mm Cannulated Drill and 7 mm Countersink, Non-Sterile |
| 10850017962092 | 6 mm x 6 mm Cannulated Drill and 6 mm Countersink, Non-Sterile |
| 10850017962085 | 5 mm x 5.5 mm Cannulated Drill and 5 mm Countersink, Non-Sterile |
| 10850017962078 | 4 mm x 5 mm Cannulated Drill and 4 mm Countersink, Non-Sterile |
| 10850017962061 | 10 mm x 10 mm S-Core Implant |
| 10850017962054 | 9 mm x 9.5 mm S-Core Implant |
| 10850017962047 | 8 mm x 9 mm S-Core Implant |
| 10850017962030 | 7 mm x 8.5 mm S-Core Implant |
| 10850017962023 | 6 mm x 8 mm S-Core Implant |
| 10850017962016 | 5 mm x 7.5 mm S-Core Implant |
| 10850017962009 | 4 mm x 7 mm S-Core Implant |
| 00850017962613 | 10mm x 8mm Drill |
| 00850017962606 | 10mm x 14mm Drill, Long |
| 10850017962597 | HA Coated 10 mm x 14 mm S-Core™ Implant W/Delivery system (00850017962583 and 00850017962439) |
| 10850017962580 | 10 mm x 14 mm Cannulated Drill Long and 10 mm Countersink (00850017962606 and 00850017962576) |
| 00850017962569 | 9mm Countersink |
| 00850017962552 | 8mm Countersink |
| 00850017962545 | 6mm Countersink |
| 00850017962538 | 6mm Countersink |
| 00850017962521 | 5mm Countersink |
| 00850017962514 | 4mm Countersink |
| 00850017962507 | 9mm x 7.5mm Drill |
| 00850017962491 | 8mm x 7mm Drill |
| 00850017962477 | 6mm x 6mm Drill |
| 00850017962460 | 5mm x 5.5mm Drill |
| 00850017962453 | 4mm x 5mm Drill |
| 00850017962446 | Cannulated Sizer Set (00850017962354, 00850017962361, 00850017962378, 00850017962385, 0085001796 |
| 10850017962436 | HA Coated 10 mm x 14 mm S-Core™ Implant |
| 00850017962422 | T10 Torque Driver |
| 00850017962415 | Size 4 Cannulated Sizer |
| 00850017962408 | Size 5 Cannulated Sizer |
| 00850017962392 | Size 6 Cannulated Sizer |
| 00850017962385 | Size 7 Cannulated Sizer |
Trademark Results [S-Core]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 S-CORE 88900220 not registered Live/Pending |
SUBCHONDRAL SOLUTIONS INC 2020-05-04 |
 S-CORE 73084842 1053940 Dead/Cancelled |
Weyerhaeuser Company 1976-04-23 |
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