WALDEMAR LINK GmbH & Co. KG

Address:Oststrasse 4-10,Norderstedt Schleswig-Holstein,DE

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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

Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented (LZO) (6) Prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate (MEH) (6) Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented (LZO) (3) Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate (MEH) (3) PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER (JWH) (1) Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented (OQG) (1) Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented (LPH) (1) PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER (KRO) (1) PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER (HSX) (1) PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER (HRY) (1)

Premarket Exempt

Clear

BiMobile Dual Mobility System Instrument - 04026575439461 Catalog Number :

Device Description : Impaction Expander, full metal version, Ø 68 mm

Device Class : 2

Duns Number: 315675488

Premarket Exempt : No

Product Code : LZO, MEH

Prescription Use : Yes

Device Count : 1

BiMobile Dual Mobility System Instrument - 04026575439478 Catalog Number :

Device Description : Impaction Expander, full metal version, Ø 70 mm

Device Class : 2

Duns Number: 315675488

Premarket Exempt : No

Product Code : LZO, MEH

Prescription Use : Yes

Device Count : 1

SP-CL Hip Stem - 04026575443413 Catalog Number : 177-340/35

Device Description : Hip Prosthesis Stem, Taper 12 / 14

Device Class : 2

Duns Number: 315675488

Premarket Exempt : No

Product Code : LZO, MEH

Prescription Use : Yes

Device Count : 1

SP-CL Hip Stem - 04026575443420 Catalog Number : 177-350/35

Device Description : Hip Prosthesis Stem, Taper 12 / 14

Device Class : 2

Duns Number: 315675488

Premarket Exempt : No

Product Code : MEH, LZO

Prescription Use : Yes

Device Count : 1

SP-CL Hip Stem - 04026575443437 Catalog Number : 177-351/35

Device Description : Hip Prosthesis Stem, Taper 12 / 14

Device Class : 2

Duns Number: 315675488

Premarket Exempt : No

Product Code : LZO, MEH

Prescription Use : Yes

Device Count : 1

SP-CL Hip Stem - 04026575443444 Catalog Number : 177-352/35

Device Description : Hip Prosthesis Stem, Taper 12 / 14

Device Class : 2

Duns Number: 315675488

Premarket Exempt : No

Product Code : MEH, LZO

Prescription Use : Yes

Device Count : 1

SP-CL Hip Stem - 04026575443451 Catalog Number : 177-353/35

Device Description : Hip Prosthesis Stem, Taper 12 / 14

Device Class : 2

Duns Number: 315675488

Premarket Exempt : No

Product Code : LZO, MEH

Prescription Use : Yes

Device Count : 1

SP-CL Hip Stem - 04026575443468 Catalog Number : 177-355/35

Device Description : Hip Prosthesis Stem, Taper 12 / 14

Device Class : 2

Duns Number: 315675488

Premarket Exempt : No

Product Code : LZO, MEH

Prescription Use : Yes

Device Count : 1

MobileLink Acetabular Cup System - 04026575443482 Catalog Number : 183-251/28

Device Description : Standard UHMWPE Insert - neutral

Device Class : 2

Duns Number: 315675488

Premarket Exempt : No

Product Code : LPH, MEH, OQG, LZO

Prescription Use : Yes

Device Count : 1

LinkSymphoKnee - 04026575443925 Catalog Number : 880-601/11

Device Description : Modular Stem, Cylindrical Press-Fit

Device Class : 2

Duns Number: 315675488

Premarket Exempt : No

Product Code : KRO, HSX, HRY, JWH

Prescription Use : Yes

Device Count : 1

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