SPARK - Instruments

GUDID 04026575217304

Orthopaedic implant inserter/extractor, reusable - Gemini SL Total Knee System

WALDEMAR LINK GmbH & Co. KG

Orthopaedic inorganic implant inserter/extractor, reusable
Primary Device ID04026575217304
NIH Device Record Key04768ded-d520-4bb0-ac31-dac52589e391
Commercial Distribution StatusIn Commercial Distribution
Brand NameSPARK - Instruments
Version Model Number445-210/00
Company DUNS315675488
Company NameWALDEMAR LINK GmbH & Co. KG
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104026575217304 [Primary]

FDA Product Code

HXGTAMP

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04026575217304]

Moist Heat or Steam Sterilization


[04026575217304]

Moist Heat or Steam Sterilization


[04026575217304]

Moist Heat or Steam Sterilization


[04026575217304]

Moist Heat or Steam Sterilization


[04026575217304]

Moist Heat or Steam Sterilization


[04026575217304]

Moist Heat or Steam Sterilization


[04026575217304]

Moist Heat or Steam Sterilization


[04026575217304]

Moist Heat or Steam Sterilization


[04026575217304]

Moist Heat or Steam Sterilization


[04026575217304]

Moist Heat or Steam Sterilization


[04026575217304]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2024-09-11
Device Publish Date2022-12-14

On-Brand Devices [SPARK - Instruments]

04026575382859Orthopaedic prosthesis implantation instrument, reusable - General Instrument
04026575216956Orthopaedic prosthesis implantation instrument, reusable - Gemini SL Total Knee System
04026575226986Orthopaedic implant aiming/guiding block, reusable - Gemini SL Total Knee System
04026575222001Orthopaedic implant aiming/guiding block, reusable - Gemini SL Total Knee System
04026575221998Orthopaedic implant aiming/guiding block, reusable - Gemini SL Total Knee System
04026575221981Orthopaedic implant aiming/guiding block, reusable - Gemini SL Total Knee System
04026575217762Orthopaedic implant aiming/guiding block, reusable - Gemini SL Total Knee System
04026575217755Orthopaedic implant aiming/guiding block, reusable - Gemini SL Total Knee System
04026575217748Orthopaedic implant aiming/guiding block, reusable - Gemini SL Total Knee System
04026575217731Orthopaedic implant aiming/guiding block, reusable - Gemini SL Total Knee System
04026575217724Orthopaedic implant aiming/guiding block, reusable - Gemini SL Total Knee System
04026575217670Orthopaedic implant aiming/guiding block, reusable - Gemini SL Total Knee System
04026575217649Orthopaedic implant aiming/guiding block, reusable - Gemini SL Total Knee System
04026575217632Orthopaedic implant aiming/guiding block, reusable - Gemini SL Total Knee System
04026575216949Orthopaedic implant aiming/guiding block, reusable - Gemini SL Total Knee System
04026575216857Orthopaedic implant aiming/guiding block, reusable - Gemini SL Total Knee System
04026575216086Orthopaedic implant aiming/guiding block, reusable - General instrument
04026575216079Orthopaedic implant aiming/guiding block, reusable - General instrument
04026575216062Orthopaedic implant aiming/guiding block, reusable - General instrument
04026575216048Orthopaedic implant aiming/guiding block, reusable - General instrument
04026575216031Orthopaedic implant aiming/guiding block, reusable - General instrument
04026575216024Orthopaedic implant aiming/guiding block, reusable - General instrument
04026575215676Orthopaedic implant aiming/guiding block, reusable - General instrument
04026575215669Orthopaedic implant aiming/guiding block, reusable - General instrument
04026575076611Orthopaedic implant aiming/guiding block, reusable - Gemini SL Total Knee System
04026575216734Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile - General Inst
04026575216727Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile - General Inst
04026575216710Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile - General Inst
04026575216703Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile - General Inst
04026575417988Knee tibia prosthesis trial - Gemini SL Total Knee System
04026575417971Knee tibia prosthesis trial - Gemini SL Total Knee System
04026575417964Knee tibia prosthesis trial - Gemini SL Total Knee System
04026575417957Knee tibia prosthesis trial - Gemini SL Total Knee System
04026575216604Knee tibia prosthesis trial - Gemini SL Total Knee System
04026575216598Knee tibia prosthesis trial - Gemini SL Total Knee System
04026575216581Knee tibia prosthesis trial - Gemini SL Total Knee System
04026575216574Knee tibia prosthesis trial - Gemini SL Total Knee System
04026575217793Orthopaedic implant inserter/extractor, reusable - Gemini SL Total Knee System
04026575217304Orthopaedic implant inserter/extractor, reusable - Gemini SL Total Knee System
04026575217007Orthopaedic implant inserter/extractor, reusable - Gemini SL Total Knee System
04026575216987Orthopaedic implant inserter/extractor, reusable - General Instrument

© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.