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™ - 00850017962309 Catalog Number : 40-0600-01

Device Description : HA Coated 6 mm x 8 mm S-Core™ Implant W/Delivery system (00850017962163 and 0085 HA Coated 6 mm x 8 mm S-Core™ Implant W/Delivery system (00850017962163 and 00850017962231)

Device Class : 2

Duns Number: 117417828

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

S-Core™ - 00850017962316 Catalog Number : 40-0700-01

Device Description : HA Coated 7 mm x 8.5 mm S-Core™ Implant W/Delivery system (00850017962170 and 00 HA Coated 7 mm x 8.5 mm S-Core™ Implant W/Delivery system (00850017962170 and 00850017962248)

Device Class : 2

Duns Number: 117417828

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

S-Core™ - 00850017962323 Catalog Number : 40-0800-01

Device Description : HA Coated 8 mm x 9 mm S-Core™ Implant W/Delivery system (00850017962187 and 0085 HA Coated 8 mm x 9 mm S-Core™ Implant W/Delivery system (00850017962187 and 00850017962255)

Device Class :

Duns Number: 117417828

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

S-Core™ - 00850017962330 Catalog Number : 40-0900-01

Device Description : HA Coated 9 mm x 9.5 mm S-Core™ Implant W/Delivery system (00850017962194 and 00 HA Coated 9 mm x 9.5 mm S-Core™ Implant W/Delivery system (00850017962194 and 00850017962262)

Device Class : 2

Duns Number: 117417828

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

S-Core™ - 00850017962347 Catalog Number : 40-1000-01

Device Description : HA Coated 10 mm x 10 mm S-Core™ Implant W/Delivery system (00850017962200 and 00 HA Coated 10 mm x 10 mm S-Core™ Implant W/Delivery system (00850017962200 and 00850017962279)

Device Class : 2

Duns Number: 117417828

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

S-Core™ - 00850017962354 Catalog Number : 10-1105

Device Description : Size 10 Cannulated Sizer

Device Class : 2

Duns Number: 117417828

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

S-Core™ - 00850017962361 Catalog Number : 10-1195

Device Description : Size 9 Cannulated Sizer

Device Class : 2

Duns Number: 117417828

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

S-Core™ - 00850017962378 Catalog Number : 10-1185

Device Description : Size 8 Cannulated Sizer

Device Class : 2

Duns Number: 117417828

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

S-Core™ - 00850017962385 Catalog Number : 10-1175

Device Description : Size 7 Cannulated Sizer

Device Class : 2

Duns Number: 117417828

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

S-Core™ - 00850017962392 Catalog Number : 10-1165

Device Description : Size 6 Cannulated Sizer

Device Class : 2

Duns Number: 117417828

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

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