FDA Registration Active 🇩🇪 Germany

Waldemar Link GmbH & Co. KG

Reg #: 3004371426 · FEI: 3003386935 · Expires 2026
Products
68
Proprietary Names
110
Establishment Types
5
Classifications
68

Registration Details

Registration Name
Waldemar Link GmbH & Co. KG
Registration Number
3004371426
FEI Number
3003386935
Status
Active
Expiry Year
2026
Initial Importer
No
Address
Oststrasse 4-10
City
Norderstedt Schleswig-Holstein
Country
DE

Regulatory Submissions

510(k) Number
K943986

Owner / Operator

Firm Name
WALDEMAR LINK GMBH & CO. KG
Operator Number
8010091
Address
BARKHAUSENWEG 10, --
City
HAMBURG
State
DE-NOTA
Postal Code
22339
Country
DE

US Agent

Business Name
LinkBio Corp.
Contact Name
Terry Sheridan Powell
Address
69 King Street
City
Dover
State
NJ
ZIP
07801
Country
US
Phone
800 9320616

Products

Device Name Product Code
Plate, Fixation, Bone HRS
Forceps HTD
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH
Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented OQG
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented JDI
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented HSD
Pliers, Surgical HTC
Prosthesis, Hip, Hemi-, Femoral, Metal KWL
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate MEH
Prosthesis, Elbow, Constrained, Cemented JDC
Prosthesis, Hip, Femoral Component, Cemented, Metal JDG
Punch, Femoral Neck HWP
Shoulder Prosthesis, Reverse Configuration PHX
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer HSX
Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer KRO
Gauge, Depth HTJ
Chisel, Surgical, Manual FZO
Guide, Surgical, Instrument FZX
Tray, Surgical, Instrument FSM
Caliper KTZ
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented LWJ
Extractor HWB
Dissector, Surgical, General & Plastic Surgery GDI
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer HRY
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive OIY
Elevator HTE
Bit, Drill HTW
Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented KWT
Template HWT
Screwdriver HXX
Wrench HXC
Retractor GAD
Blade, Scalpel GES
Cap, Bone JDT
Starter, Bone Screw HWD
Crimper, Pin HXQ
Scissors, Orthopedic, Surgical HRR
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented PAO
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE
Driver, Prosthesis HWR
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented KWY
Pusher, Socket HXO
Curette HTF
Awl HWJ
Clamp, Surgical, General & Plastic Surgery GDJ
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer MBH
Hammer, Surgical FZY
Tamp HXG
Gouge, Surgical, General & Plastic Surgery GDH
Cutter, Wire HXZ
Brace, Drill HXY
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented KWS
Spatula, Orthopedic HXR
Rasp HTR
Holder, Needle; Orthopedic HXK
Rongeur HTX
Orthopedic Manual Surgical Instrument LXH
Splint, Hand, And Components ILH
Stylet, Surgical, General & Plastic Surgery GAH
Chisel (Osteotome) KDG
Broach HTQ
Instrument, Compression HWN
Hook, Surgical, General & Plastic Surgery GDG
Reamer HTO
Impactor HWA
Handle, Scalpel GDZ

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 Kerrison bone cutting forceps; bone rongeur forceps Handle, Grip, Adapter, Rod, Applicator Vario-Cup System LINK MP Monoblock Hip Prosthesis LINK Endo-Model EVO Knee System Toe Splint Finger Splint Guide Rod, Guide Wire Bone Chisel, Osteotome Broach, Compressor Link Ceramic Head 12/14 x 32mm custom pelvic reconstructions with extensive plating features MobileLink Bone Screws compressor MP Reconstruction Hip LINK Embrace Shoulder System - Line Extension Hook, General Hand Instruments, Spreads reamers HOLDER AND DRIVER FOR REIMER acetabular custom-made devices LCU and SP-CL Hip Stem - HX (CaP) inhouse coating SPAR-K Instruments Needle, Scalpel LINK GEMINI SL Total Knee System BiMobile Dual Mobility System - E-Dur Inserts Custom Modular Stem Segment with Neck Segment inkl. Modular Stem LINK Embrace Shoulder System - Reverse Configuration Modular

Establishment Types

Manufacture Medical Device Remanufacture Medical Device Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility