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 - 00816127022142 Catalog Number : 10-11-0007

Device Description : Femoral Stem, Size 7, Lateralized

Device Class : 2

Duns Number: 060211165

Premarket Exempt : No

Product Code : OQI, OQG, LZO, LPH

Prescription Use : Yes

Device Count : 1

InSitu Hip System - 00816127022159 Catalog Number : 10-11-0008

Device Description : Femoral Stem, Size 8, Lateralized

Device Class : 2

Duns Number: 060211165

Premarket Exempt : No

Product Code : LPH, LZO, OQG, OQI

Prescription Use : Yes

Device Count : 1

InSitu Hip System - 00816127022166 Catalog Number : 10-11-0009

Device Description : Femoral Stem, Size 9, Lateralized

Device Class : 2

Duns Number: 060211165

Premarket Exempt : No

Product Code : OQI, OQG, LZO, LPH

Prescription Use : Yes

Device Count : 1

InSitu Hip System - 00816127022173 Catalog Number : 10-11-0010

Device Description : Femoral Stem, Size 10, Lateralized

Device Class : 2

Duns Number: 060211165

Premarket Exempt : No

Product Code : LPH, LZO, OQG, OQI

Prescription Use : Yes

Device Count : 1

InSitu Hip System - 00816127022180 Catalog Number : 10-11-0011

Device Description : Femoral Stem, Size 11, Lateralized

Device Class : 2

Duns Number: 060211165

Premarket Exempt : No

Product Code : OQI, OQG, LZO, LPH

Prescription Use : Yes

Device Count : 1

InSitu Hip System - 00816127022197 Catalog Number : 10-11-0012

Device Description : Femoral Stem, Size 12, Lateralized

Device Class : 2

Duns Number: 060211165

Premarket Exempt : No

Product Code : LPH, LZO, OQG, OQI

Prescription Use : Yes

Device Count : 1

InSitu Hip System - 00816127022203 Catalog Number : 10-11-0013

Device Description : Femoral Stem, Size 13, Lateralized

Device Class : 2

Duns Number: 060211165

Premarket Exempt : No

Product Code : OQI, OQG, LZO, LPH

Prescription Use : Yes

Device Count : 1

InSitu Hip System - 00816127022210 Catalog Number : 10-11-0014

Device Description : Femoral Stem, Size 14, Lateralized

Device Class : 2

Duns Number: 060211165

Premarket Exempt : No

Product Code : LPH, LZO, OQG, OQI

Prescription Use : Yes

Device Count : 1

InSitu Hip System - 00816127022227 Catalog Number : 10-20-2800

Device Description : Femoral Head, 28mm, -3.5mm, 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 - 00816127022234 Catalog Number : 10-20-2801

Device Description : Femoral Head, 28mm, 0mm, CoCr

Device Class : 2

Duns Number: 060211165

Premarket Exempt : No

Product Code : LPH, LZO, OQG, OQI

Prescription Use : Yes

Device Count : 1

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