Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004371426

FEI Number

3003386935

Entity Name

Waldemar Link GmbH & Co. KG

City/State/Country

Norderstedt Schleswig-Holstein, DE

Establishment Address

Oststrasse 4-10, Norderstedt Schleswig-Holstein 22844, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

WALDEMAR LINK GMBH & CO. KG (Owner Number: 8010091)

Owner / Operator Contact Address

BARKHAUSENWEG 10, --, HAMBURG, DE-NOTA 22339, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Partial Pelvis forceps LINK MobileLink Acetabular Cup System - TrabecuLink Shells MP Reconstruction System, cemented prosthesis stems Custom Made Shoulder Head Pliers, Approximator Link Saddle Prosthesis BiMobile Instruments custom made elbow replacements Custom Made Distal Humeral Replacement incl. Humeral Cone Lubinus SPII Hip System Tibial Keel Punch Custom made Glenoid replacement TrabecuLink, inverse Custom Made Glenosphere LINK PorEx (TiNbN) inhouse coating for GEMINI SL Total Knee System, Endo-Model Knee System, Sled Knee System gouge Chisel Drill and Saw Guides trays Caliper MP Hip Revision System LINK® SP-CL® Hip System PoroLink® (microporous) and HX® (CaP) coated LINK® LCU® Hip System PoroLink® (microporous) and HX® (CaP) coated Extractor Dissector, Plugger Endo Knee LinkSymphoKnee System Phalangeal Elevator Drill Bit, Cutting Drill LINK® Sled Knee System with PorEx® (TiNbN) coating LINK® Endo-Model® Knee System with PorEx® (TiNbN) coating Custom Made Humeral Stem TRIAL CUP INSTRUMENT FEMORAL ANGLE CUTTING TEMPLATE TEMPLATE Reamers Torque Wrench, Screw Drivers Key RETRACTOR BLADES Blade Metal Caps Screw, Fixation Screw, Distraction Screw Wire Pin, Drill Pin IP Acetabular Cups scissor MobileLink Acetabular Cup System inhouse coatings LINK Embrace Shoulder System - Reverse Configuration AC-POWERED MOTORED AND ACCESSORY / ATTACHMENT Driver Vario-Head Endo-Prosthesis System Pusher Curettes MobileLink Acetabular Cup System Awl Custom made Hip Prosthesis stem, uncemented, TiCaP coating LINK Endo-Model Total Knee System, Femoral Segments (Augments), UHMWPE Custom Made LINK Femoral and Tibial OptiStem Megasystem-C, uncemented polished Custom Made Coupling for Fusion Nail Megasystem-C, cemented Prox. femoral modular stem Megasystem-C, uncemented, HX Rotational segment Megasystem-C Distal femoral modular stem Megasystem-C, uncemented, HX Knee prosthesis LinkSymphoKnee, femoral and tibial, cemented Link Megasystem-C, Endo-Model SL Clamp Feldmuehle Ceramic Head 12/14x28mm MobileLink Acetabular Cup System - Dual Mobility Liners and Shell/Insert Adapters LINK TrabecuLink Femoral Cones LINK TrabecuLink Tibial Cones Mallet BiMobile Dual Mobility System Bone Tamper Custom Made LINK Femoral Rescue Sleeve with stem and flange, cemented LinkSymphoKnee UC Gouge Wire Cutter Drive Shaft; Brace; Drill Allure Hip Stem Sled Uni-Compartment Knee System LINK Embrace Shoulder System - Anatomical Configuration Monoblock Spatula MobileLink Acetabular Cup System - X-LINKed Inserts and TrabecuLink Augments Rasp, Rasp Stem Needle Holder

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2008-02-08
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	1981-09-25
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2023-04-17
OQG	Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented	Orthopedic	Class 2	888.3358	2023-04-17
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2022-04-25
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2022-04-25
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2020-09-09
HTC	Pliers, Surgical	General, Plastic Surgery	Class 1	878.4800	1978-01-30
KWL	Prosthesis, Hip, Hemi-, Femoral, Metal	Orthopedic	Class 2	888.3360	2008-02-12
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2022-06-07
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2022-06-07
JDC	Prosthesis, Elbow, Constrained, Cemented	Orthopedic	Class 2	888.3150	2020-05-25
JDG	Prosthesis, Hip, Femoral Component, Cemented, Metal	Orthopedic	Class 2	888.3360	2008-02-08
HWP	Punch, Femoral Neck	Orthopedic	Class 1	888.4540	2021-05-18
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2022-10-06
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2021-09-20
HSX	Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3520	2021-09-20
KRO	Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3510	2021-09-20
HTJ	Gauge, Depth	Orthopedic	Class 1	888.4300	1978-01-25
FZO	Chisel, Surgical, Manual	General, Plastic Surgery	Class 1	878.4800	2025-08-28
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2015-01-07
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	1978-01-09
KTZ	Caliper	Orthopedic	Class 1	888.4150	1978-01-30
LWJ	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3360	2014-11-10
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2014-11-10
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2014-11-10
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2017-03-17
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2017-03-17
HWB	Extractor	Orthopedic	Class 1	888.4540	1978-01-16
GDI	Dissector, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2015-01-07
KRO	Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3510	2008-02-08
HRY	Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3530	2021-05-14
KRO	Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3510	2021-05-14
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2021-05-14
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Orthopedic	Class 2	888.3560	2021-05-14
HSX	Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3520	2021-05-14
HTE	Elevator	General, Plastic Surgery	Class 1	878.4800	2013-11-01
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2012-02-10
KRO	Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3510	2016-05-17
HSX	Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3520	2016-05-17
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2020-09-09
HWT	Template	Orthopedic	Class 1	888.4800	1978-03-15
HXX	Screwdriver	Orthopedic	Class 1	888.4540	1978-01-10
HXC	Wrench	Orthopedic	Class 1	888.4540	1978-03-14
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2012-02-10
GES	Blade, Scalpel	General, Plastic Surgery	Class 1	878.4800	2012-02-10
JDT	Cap, Bone	Orthopedic	Class 1	888.3000	1978-01-25
HWD	Starter, Bone Screw	Orthopedic	Class 1	888.4540	1978-01-30
HXQ	Crimper, Pin	Orthopedic	Class 1	888.4540	1978-03-14
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2008-02-08
HRR	Scissors, Orthopedic, Surgical	Orthopedic	Class 1	888.4540	2012-02-10
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2025-05-20
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2025-05-20
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2021-02-08
PAO	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented	Orthopedic	Class 2	888.3660	2021-02-08
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2021-02-08
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2023-11-17
HWR	Driver, Prosthesis	Orthopedic	Class 1	888.4540	1978-03-15
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2008-02-08
HXO	Pusher, Socket	Orthopedic	Class 1	888.4540	1978-03-14
HTF	Curette	General, Plastic Surgery	Class 1	878.4800	2015-01-07
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2019-07-04
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2019-07-04
OQG	Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented	Orthopedic	Class 2	888.3358	2019-07-04
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2019-07-04
HWJ	Awl	Orthopedic	Class 1	888.4540	1978-01-09
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2020-11-03
KRO	Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3510	2021-07-05
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2021-07-05
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2021-07-05
LWJ	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3360	2021-07-05
KRO	Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3510	2021-04-28
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2015-08-27
LWJ	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3360	2015-08-27
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2015-08-27
KRO	Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3510	2015-08-27
GDJ	Clamp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2012-02-10
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2008-02-12
OQG	Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented	Orthopedic	Class 2	888.3358	2021-05-29
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2021-05-29
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2020-07-21
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2020-03-18
FZY	Hammer, Surgical	General, Plastic Surgery	Class 1	878.4800	2015-01-07
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2018-01-22
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2018-01-22
HXG	Tamp	Orthopedic	Class 1	888.4540	1978-03-15
KWL	Prosthesis, Hip, Hemi-, Femoral, Metal	Orthopedic	Class 2	888.3360	2020-12-14
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2023-03-22
GDH	Gouge, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2017-05-12
HXZ	Cutter, Wire	Orthopedic	Class 1	888.4540	2012-02-10
HXY	Brace, Drill	Orthopedic	Class 1	888.4540	1978-01-30
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2025-11-20
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2025-11-20
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2025-11-20
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2025-11-20
OQG	Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented	Orthopedic	Class 2	888.3358	2025-11-20
HSX	Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3520	2008-02-12
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2021-06-22
PAO	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented	Orthopedic	Class 2	888.3660	2021-06-22
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2021-06-22
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2021-06-22
HXR	Spatula, Orthopedic	General, Plastic Surgery	Class 1	878.4800	2012-02-10
KRO	Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3510	2015-02-06
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2024-11-11
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2024-11-11
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2024-11-11
HTR	Rasp	General, Plastic Surgery	Class 1	878.4800	1981-09-25
HXK	Holder, Needle; Orthopedic	Orthopedic	Class 1	888.4540	2012-02-10

Official Correspondent

No official correspondent registered.

US Agent Details

Terry Sheridan Powell Business: LinkBio Corp. Email: t.powell@linkbio.com Phone: (800) 9320616

Related Public Records

Same Entity

WALDEMAR LINK GMBH & CO. KG

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
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K042598	Zimmer, Inc.	PERIARTICULAR LOCKING PLATES AND SCREWS, 2357 AND 2359 SERIES	2004-10-29
K190842	Jiangsu Trauhui Medical Instrument Co., Ltd.	Comus Locking Plate systems	2020-02-03
K130510	Arthrex, Inc.	ARTHREX COMPRESSION PLATES	2013-09-25
K202803	Newclip Technics	Activmotion S DTO	2021-12-16

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0034-2022	Flower Orthopedics Corporation	2	Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201
Z-0032-2009	Biomet, Inc.	2	Biomet brand Discovery Elbow, 3 mm x 75 mm right ulna with bearing/bond coat, TI 6AL 4V Alloy/ARCOM UHMWPE, For cemented use only, sterile, Biomet Orthopedics, Inc., Warsaw, IN; REF 114813. The product intended use is for Orthopedic implant.
Z-0033-2009	Biomet, Inc.	2	Biomet brand Discovery Elbow, 3 mm x 115 mm right ulna with bearing/bond coat, TI 6AL 4V Alloy/ARCOM UHMWPE, For cemented use only, sterile, Biomet Orthopedics, Inc., Warsaw, IN; REF 114817. The product intended use is for Orthopedic implant.
Z-0001-2019	Smith & Nephew, Inc.	2	Journey BCS Knee CoCr Femoral Components, Catalog Numbers: 74021210, 74021211, 74021212, 74021213, 74021214, 74021215, 74021216, 74021217, 74021218, 74021219, 74021220, 74021221, 74021222, 74021223, 74021224, 74021225, 74021226, 74021227, 74021228, 74021229
Z-0002-2019	Smith & Nephew, Inc.	2	JOURNEY BCS OXINIUM Knee Femoral Components, Catalog Numbers: 74021110, 74021111, 74021112, 74021113, 74021114, 74021115, 74021116, 74021117, 74021118, 74021119, 74021120, 74021121, 74021122, 74021123, 74021124, 74021125, 74021126, 74021127, 74021128, 74021129, 74021130, 74021131, 74021132, 74021133, 74021134, 74021135, 74021136, 74021137, 74021138, 74021139, 74021140, 74021141, 74021142, 74021143, 74021144, 74021145, 74021146, 74021147, 74021148, 74021149

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004371426. Last updated year: 2026. Please use registration number 3004371426 when referencing this establishment in official correspondence.