SUBCHONDRAL SOLUTIONS, INC.

Address:7146 Edinger Ave,Huntington Beach,CA,92647,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Screw, Fixation, Bone (HWC) (10)

Premarket Exempt

Clear

S-Core™ - 00850017962514 Catalog Number : 10-1040

Device Description : 4mm Countersink

Device Class : 2

Duns Number: 117417828

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

S-Core™ - 00850017962521 Catalog Number : 10-1050

Device Description : 5mm Countersink

Device Class : 2

Duns Number: 117417828

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

S-Core™ - 00850017962538 Catalog Number : 10-1060

Device Description : 6mm Countersink

Device Class : 2

Duns Number: 117417828

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

S-Core™ - 00850017962545 Catalog Number : 10-1070

Device Description : 6mm Countersink

Device Class : 2

Duns Number: 117417828

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

S-Core™ - 00850017962552 Catalog Number : 10-1080

Device Description : 8mm Countersink

Device Class : 2

Duns Number: 117417828

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

S-Core™ - 00850017962569 Catalog Number : 10-1090

Device Description : 9mm Countersink

Device Class : 2

Duns Number: 117417828

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

S-Core™ - 00850017962583 Catalog Number : 10-2014-S

Device Description : 10 mm x 14 mm Cannulated Drill Long and 10 mm Countersink (00850017962606 and 00 10 mm x 14 mm Cannulated Drill Long and 10 mm Countersink (00850017962606 and 00850017962576)

Device Class : 2

Duns Number: 117417828

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

S-Core™ - 00850017962590 Catalog Number : 40-1014-01

Device Description : HA Coated 10 mm x 14 mm S-Core™ Implant W/Delivery system (00850017962583 and 00 HA Coated 10 mm x 14 mm S-Core™ Implant W/Delivery system (00850017962583 and 00850017962439)

Device Class : 2

Duns Number: 117417828

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

S-Core™ - 00850017962606 Catalog Number : 10-0210

Device Description : 10mm x 14mm Drill, Long

Device Class : 2

Duns Number: 117417828

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

S-Core™ - 00850017962613 Catalog Number : 10-0010

Device Description : 10mm x 8mm Drill

Device Class : 2

Duns Number: 117417828

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

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