WALDEMAR LINK GmbH & Co. KG

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

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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

PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER (JWH) (5) Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented (LZO) (5) Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate (MEH) (5)

Premarket Exempt

Clear

LINK Instrument - 04026575437375 Catalog Number : 317-810/10

Device Description : Spacer

Device Class : 2

Duns Number: 315675488

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

LINK Instrument - 04026575437382 Catalog Number : 317-810/12

Device Description : Spacer

Device Class : 2

Duns Number: 315675488

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

LINK Instrument - 04026575437399 Catalog Number : 317-810/14

Device Description : Spacer

Device Class : 2

Duns Number: 315675488

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

LINK Instrument - 04026575437405 Catalog Number : 317-810/16

Device Description : Spacer

Device Class : 2

Duns Number: 315675488

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

LINK Instrument - 04026575437412 Catalog Number : 317-730/25

Device Description : Trial Plateau

Device Class : 2

Duns Number: 315675488

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

BiMobile Dual Mobility System Instrument - 04026575439317 Catalog Number :

Device Description : Alignment Guide

Device Class : 2

Duns Number: 315675488

Premarket Exempt : No

Product Code : LZO, MEH

Prescription Use : Yes

Device Count : 1

BiMobile Dual Mobility System Instrument - 04026575439324 Catalog Number :

Device Description : Impactor Handle

Device Class : 2

Duns Number: 315675488

Premarket Exempt : No

Product Code : MEH, LZO

Prescription Use : Yes

Device Count : 1

BiMobile Dual Mobility System Instrument - 04026575439331 Catalog Number :

Device Description : Impaction Expander, full metal version, Ø 42 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 - 04026575439348 Catalog Number :

Device Description : Impaction Expander, full metal version, Ø 44 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 - 04026575439355 Catalog Number :

Device Description : Impaction Expander, full metal version, Ø 46 mm

Device Class : 2

Duns Number: 315675488

Premarket Exempt : No

Product Code : MEH, LZO

Prescription Use : Yes

Device Count : 1

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