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 - 00816127022043 Catalog Number : 10-10-0011

Device Description : Femoral Stem, Size 11, Standard

Device Class : 2

Duns Number: 060211165

Premarket Exempt : No

Product Code : LPH, LZO, OQG, OQI

Prescription Use : Yes

Device Count : 1

InSitu Hip System - 00816127022050 Catalog Number : 10-10-0012

Device Description : Femoral Stem, Size 12, Standard

Device Class : 2

Duns Number: 060211165

Premarket Exempt : No

Product Code : OQI, OQG, LZO, LPH

Prescription Use : Yes

Device Count : 1

InSitu Hip System - 00816127022067 Catalog Number : 10-10-0013

Device Description : Femoral Stem, Size 13, Standard

Device Class : 2

Duns Number: 060211165

Premarket Exempt : No

Product Code : LPH, LZO, OQG, OQI

Prescription Use : Yes

Device Count : 1

InSitu Hip System - 00816127022074 Catalog Number : 10-10-0014

Device Description : Femoral Stem, Size 14, Standard

Device Class : 2

Duns Number: 060211165

Premarket Exempt : No

Product Code : OQI, OQG, LZO, LPH

Prescription Use : Yes

Device Count : 1

InSitu Hip System - 00816127022081 Catalog Number : 10-11-0001

Device Description : Femoral Stem, Size 1, 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 - 00816127022098 Catalog Number : 10-11-0002

Device Description : Femoral Stem, Size 2, 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 - 00816127022104 Catalog Number : 10-11-0003

Device Description : Femoral Stem, Size 3, 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 - 00816127022111 Catalog Number : 10-11-0004

Device Description : Femoral Stem, Size 4, 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 - 00816127022128 Catalog Number : 10-11-0005

Device Description : Femoral Stem, Size 5, 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 - 00816127022135 Catalog Number : 10-11-0006

Device Description : Femoral Stem, Size 6, Lateralized

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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