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 - 00816127021947 Catalog Number : 10-10-0001

Device Description : Femoral Stem, Size 1, 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 - 00816127021954 Catalog Number : 10-10-0002

Device Description : Femoral Stem, Size 2, 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 - 00816127021961 Catalog Number : 10-10-0003

Device Description : Femoral Stem, Size 3, 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 - 00816127021978 Catalog Number : 10-10-0004

Device Description : Femoral Stem, Size 4, 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 - 00816127021985 Catalog Number : 10-10-0005

Device Description : Femoral Stem, Size 5, 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 - 00816127021992 Catalog Number : 10-10-0006

Device Description : Femoral Stem, Size 6, 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 - 00816127022005 Catalog Number : 10-10-0007

Device Description : Femoral Stem, Size 7, 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 - 00816127022012 Catalog Number : 10-10-0008

Device Description : Femoral Stem, Size 8, 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 - 00816127022029 Catalog Number : 10-10-0009

Device Description : Femoral Stem, Size 9, 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 - 00816127022036 Catalog Number : 10-10-0010

Device Description : Femoral Stem, Size 10, Standard

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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