NEXTSTEP ARTHROPEDIX, LLC

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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

Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented (OQG) (10) Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented (OQI) (10) Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented (LZO) (10) Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented (LPH) (10)

Premarket Exempt

Clear

InSitu Hip System - 00816127022548 Catalog Number : 10-21-4002

Device Description : Femoral Head, 40mm, +4mm, Biolox

Device Class : 2

Duns Number: 060211165

Premarket Exempt : No

Product Code : LPH, LZO, OQG, OQI

Prescription Use : Yes

Device Count : 1

InSitu Hip System - 00816127022555 Catalog Number : 10-21-4003

Device Description : Femoral Head, 40mm, +8mm, Biolox

Device Class : 2

Duns Number: 060211165

Premarket Exempt : No

Product Code : OQI, OQG, LZO, LPH

Prescription Use : Yes

Device Count : 1

InSitu Hip System - 00816127022562 Catalog Number : 10-32-0046

Device Description : Acetabular Cup, Size 46, Holed, Anodized

Device Class : 2

Duns Number: 060211165

Premarket Exempt : No

Product Code : OQI, LPH, LZO, OQG

Prescription Use : Yes

Device Count : 1

InSitu Hip System - 00816127022579 Catalog Number : 10-32-0048

Device Description : Acetabular Cup, Size 48, Holed, Anodized

Device Class : 2

Duns Number: 060211165

Premarket Exempt : No

Product Code : OQG, LZO, LPH, OQI

Prescription Use : Yes

Device Count : 1

InSitu Hip System - 00816127022586 Catalog Number : 10-32-0050

Device Description : Acetabular Cup, Size 50, Holed, Anodized

Device Class : 2

Duns Number: 060211165

Premarket Exempt : No

Product Code : OQI, LPH, LZO, OQG

Prescription Use : Yes

Device Count : 1

InSitu Hip System - 00816127022593 Catalog Number : 10-32-0052

Device Description : Acetabular Cup, Size 52, Holed, Anodized

Device Class : 2

Duns Number: 060211165

Premarket Exempt : No

Product Code : OQG, LZO, LPH, OQI

Prescription Use : Yes

Device Count : 1

InSitu Hip System - 00816127022609 Catalog Number : 10-32-0054

Device Description : Acetabular Cup, Size 54, Holed, Anodized

Device Class : 2

Duns Number: 060211165

Premarket Exempt : No

Product Code : OQI, LPH, LZO, OQG

Prescription Use : Yes

Device Count : 1

InSitu Hip System - 00816127022616 Catalog Number : 10-32-0056

Device Description : Acetabular Cup, Size 56, Holed, Anodized

Device Class : 2

Duns Number: 060211165

Premarket Exempt : No

Product Code : OQG, LZO, LPH, OQI

Prescription Use : Yes

Device Count : 1

InSitu Hip System - 00816127022623 Catalog Number : 10-32-0058

Device Description : Acetabular Cup, Size 58, Holed, Anodized

Device Class : 2

Duns Number: 060211165

Premarket Exempt : No

Product Code : OQI, LPH, LZO, OQG

Prescription Use : Yes

Device Count : 1

InSitu Hip System - 00816127022630 Catalog Number : 10-32-0060

Device Description : Acetabular Cup, Size 60, Holed, Anodized

Device Class : 2

Duns Number: 060211165

Premarket Exempt : No

Product Code : OQG, LZO, LPH, OQI

Prescription Use : Yes

Device Count : 1

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