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 - 00816127022340 Catalog Number : 10-20-3603

Device Description : Femoral Head, 36mm, +8mm, CoCr

Device Class : 2

Duns Number: 060211165

Premarket Exempt : No

Product Code : OQI, OQG, LZO, LPH

Prescription Use : Yes

Device Count : 1

InSitu Hip System - 00816127022357 Catalog Number : 10-20-3604

Device Description : Femoral Head, 36mm, +10mm, CoCr Skirted

Device Class : 2

Duns Number: 060211165

Premarket Exempt : No

Product Code : LPH, LZO, OQG, OQI

Prescription Use : Yes

Device Count : 1

InSitu Hip System - 00816127022364 Catalog Number : 10-20-4000

Device Description : Femoral Head, 40mm, -4mm, CoCr

Device Class : 2

Duns Number: 060211165

Premarket Exempt : No

Product Code : OQI, OQG, LZO, LPH

Prescription Use : Yes

Device Count : 1

InSitu Hip System - 00816127022371 Catalog Number : 10-20-4001

Device Description : Femoral Head, 40mm, 0mm, CoCr

Device Class : 2

Duns Number: 060211165

Premarket Exempt : No

Product Code : LPH, LZO, OQG, OQI

Prescription Use : Yes

Device Count : 1

InSitu Hip System - 00816127022388 Catalog Number : 10-20-4002

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

Device Class : 2

Duns Number: 060211165

Premarket Exempt : No

Product Code : OQI, OQG, LZO, LPH

Prescription Use : Yes

Device Count : 1

InSitu Hip System - 00816127022395 Catalog Number : 10-20-4003

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

Device Class : 2

Duns Number: 060211165

Premarket Exempt : No

Product Code : LPH, LZO, OQG, OQI

Prescription Use : Yes

Device Count : 1

InSitu Hip System - 00816127022401 Catalog Number : 10-20-4004

Device Description : Femoral Head, 40mm, +10mm, CoCr Skirted

Device Class : 2

Duns Number: 060211165

Premarket Exempt : No

Product Code : OQI, OQG, LZO, LPH

Prescription Use : Yes

Device Count : 1

InSitu Hip System - 00816127022418 Catalog Number : 10-21-2800

Device Description : Femoral Head, 28mm, -3.5mm, 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 - 00816127022425 Catalog Number : 10-21-2801

Device Description : Femoral Head, 28mm, 0mm, 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 - 00816127022432 Catalog Number : 10-21-2802

Device Description : Femoral Head, 28mm, +3.5mm, Biolox

Device Class : 2

Duns Number: 060211165

Premarket Exempt : No

Product Code : OQI, OQG, LZO, LPH

Prescription Use : Yes

Device Count : 1

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