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™ - 00850017962200 Catalog Number : 20-1000-01-P

Device Description : HA Coated 10 mm x 10 mm S-Core Implant

Device Class : 2

Duns Number: 117417828

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

S-Core™ - 00850017962217 Catalog Number : 10-2004-S

Device Description : 4 mm x 5mm Cannulated Drill and 4 mm Countersink (00850017962514 and 00850017962453)

Device Class : 2

Duns Number: 117417828

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

S-Core™ - 00850017962224 Catalog Number : 10-2005-S

Device Description : 5 mm x 5.5 mm Cannulated Drill and 5 mm Countersink (00850017962521 and 00850017962460)

Device Class : 2

Duns Number: 117417828

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

S-Core™ - 00850017962231 Catalog Number : 10-2006-S

Device Description : 6 mm x 6 mm Cannulated Drill and 6 mm Countersink (00850017962538 and 00850017962477)

Device Class : 2

Duns Number: 117417828

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

S-Core™ - 00850017962248 Catalog Number : 10-2007-S

Device Description : 7 mm x 6.5 mm Cannulated Drill and 7 mm Countersink (00850017962545 and 00850017962484)

Device Class : 2

Duns Number: 117417828

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

S-Core™ - 00850017962255 Catalog Number : 10-2008-S

Device Description : 8 mm x 7 mm Cannulated Drill and 8 mm Countersink (00850017962552 and 00850017962491)

Device Class : 2

Duns Number: 117417828

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

S-Core™ - 00850017962262 Catalog Number : 10-2009-S

Device Description : 9 mm x 7.5 mm Cannulated Drill and 9 mm Countersink (00850017962569 and 00850017962507)

Device Class : 2

Duns Number: 117417828

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

S-Core™ - 00850017962279 Catalog Number : 10-2010-S

Device Description : 10 mm x 8 mm Cannulated Drill and 10 mm Countersink (00850017962576 and 00850017962613)

Device Class : 2

Duns Number: 117417828

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

S-Core™ - 00850017962286 Catalog Number : 40-0400-01

Device Description : HA Coated 4 mm x 7 mm S-Core™ Implant W/Delivery system (00850017962149 and 0085 HA Coated 4 mm x 7 mm S-Core™ Implant W/Delivery system (00850017962149 and 00850017962217)

Device Class : 2

Duns Number: 117417828

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

S-Core™ - 00850017962293 Catalog Number : 40-0500-01

Device Description : HA Coated 5 mm x 7.5 mm S-Core™ Implant W/Delivery system (00850017962156 and 00 HA Coated 5 mm x 7.5 mm S-Core™ Implant W/Delivery system (00850017962156 and 00850017962224)

Device Class : 2

Duns Number: 117417828

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

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