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
- [email protected]
- Phone
- 800 9320616
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2008-02-08 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 1981-09-25 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2023-04-17 |
| Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | OQG | Class 2 | Orthopedic | No | 2023-04-17 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2022-04-25 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2022-04-25 |
| Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | HSD | Class 2 | Orthopedic | No | 2020-09-09 |
| Pliers, Surgical | HTC | Class 1 | General, Plastic Surgery | No | 1978-01-30 |
| Prosthesis, Hip, Hemi-, Femoral, Metal | KWL | Class 2 | Orthopedic | No | 2008-02-12 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | MEH | Class 2 | Orthopedic | No | 2022-06-07 |
| Prosthesis, Elbow, Constrained, Cemented | JDC | Class 2 | Orthopedic | No | 2020-05-25 |
| Prosthesis, Hip, Femoral Component, Cemented, Metal | JDG | Class 2 | Orthopedic | No | 2008-02-08 |
| Punch, Femoral Neck | HWP | Class 1 | Orthopedic | No | 2021-05-18 |
| Shoulder Prosthesis, Reverse Configuration | PHX | Class 2 | Orthopedic | No | 2022-10-06 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2021-09-20 |
| Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | HSX | Class 2 | Orthopedic | No | 2021-09-20 |
| Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | KRO | Class 2 | Orthopedic | No | 2021-09-20 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 1978-01-25 |
| Chisel, Surgical, Manual | FZO | Class 1 | General, Plastic Surgery | No | 2025-08-28 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2015-01-07 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 1978-01-09 |
| Caliper | KTZ | Class 1 | Orthopedic | No | 1978-01-30 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | LWJ | Class 2 | Orthopedic | No | 2014-11-10 |
| Extractor | HWB | Class 1 | Orthopedic | No | 1978-01-16 |
| Dissector, Surgical, General & Plastic Surgery | GDI | Class 1 | General, Plastic Surgery | No | 2015-01-07 |
| Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | HRY | Class 2 | Orthopedic | No | 2021-05-14 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | OIY | Class 2 | Orthopedic | No | 2021-05-14 |
| Elevator | HTE | Class 1 | General, Plastic Surgery | No | 2013-11-01 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2012-02-10 |
| Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | KWT | Class 2 | Orthopedic | No | 2020-09-09 |
| Template | HWT | Class 1 | Orthopedic | No | 1978-03-15 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 1978-01-10 |
| Wrench | HXC | Class 1 | Orthopedic | No | 1978-03-14 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2012-02-10 |
| Blade, Scalpel | GES | Class 1 | General, Plastic Surgery | No | 2012-02-10 |
| Cap, Bone | JDT | Class 1 | Orthopedic | No | 1978-01-25 |
| Starter, Bone Screw | HWD | Class 1 | Orthopedic | No | 1978-01-30 |
| Crimper, Pin | HXQ | Class 1 | Orthopedic | No | 1978-03-14 |
| Scissors, Orthopedic, Surgical | HRR | Class 1 | Orthopedic | No | 2012-02-10 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented | PAO | Class 2 | Orthopedic | No | 2021-02-08 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2023-11-17 |
| Driver, Prosthesis | HWR | Class 1 | Orthopedic | No | 1978-03-15 |
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | KWY | Class 2 | Orthopedic | No | 2008-02-08 |
| Pusher, Socket | HXO | Class 1 | Orthopedic | No | 1978-03-14 |
| Curette | HTF | Class 1 | General, Plastic Surgery | No | 2015-01-07 |
| Awl | HWJ | Class 1 | Orthopedic | No | 1978-01-09 |
| Clamp, Surgical, General & Plastic Surgery | GDJ | Class 1 | General, Plastic Surgery | No | 2012-02-10 |
| Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | MBH | Class 2 | Orthopedic | No | 2020-07-21 |
| Hammer, Surgical | FZY | Class 1 | General, Plastic Surgery | No | 2015-01-07 |
| Tamp | HXG | Class 1 | Orthopedic | No | 1978-03-15 |
| Gouge, Surgical, General & Plastic Surgery | GDH | Class 1 | General, Plastic Surgery | No | 2017-05-12 |
| Cutter, Wire | HXZ | Class 1 | Orthopedic | No | 2012-02-10 |
| Brace, Drill | HXY | Class 1 | Orthopedic | No | 1978-01-30 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | KWS | Class 2 | Orthopedic | No | 2021-06-22 |
| Spatula, Orthopedic | HXR | Class 1 | General, Plastic Surgery | No | 2012-02-10 |
| Rasp | HTR | Class 1 | General, Plastic Surgery | No | 1981-09-25 |
| Holder, Needle; Orthopedic | HXK | Class 1 | Orthopedic | No | 2012-02-10 |
| Rongeur | HTX | Class 1 | Orthopedic | No | 2012-02-10 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2015-01-07 |
| Splint, Hand, And Components | ILH | Class 1 | Physical Medicine | No | 1978-03-14 |
| Stylet, Surgical, General & Plastic Surgery | GAH | Class 1 | General, Plastic Surgery | No | 2015-01-07 |
| Chisel (Osteotome) | KDG | Class 1 | General, Plastic Surgery | No | 2012-02-10 |
| Broach | HTQ | Class 1 | Orthopedic | No | 1978-01-16 |
| Instrument, Compression | HWN | Class 1 | Orthopedic | No | 1978-03-14 |
| Hook, Surgical, General & Plastic Surgery | GDG | Class 1 | General, Plastic Surgery | No | 2012-02-10 |
| Reamer | HTO | Class 1 | Orthopedic | No | 1978-03-15 |
| Impactor | HWA | Class 1 | Orthopedic | No | 1978-03-16 |
| Handle, Scalpel | GDZ | Class 1 | General, Plastic Surgery | No | 2012-02-10 |
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