NK 1020-20

GUDID 04042409049002

K-wire with thread and trocar point, ø2.0, L 200

aap Implantate AG

Orthopaedic bone wire
Primary Device ID04042409049002
NIH Device Record Keycb2b4528-6d49-49af-b675-f2a519a0f782
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberNK 1020-20
Catalog NumberNK 1020-20
Company DUNS328420633
Company Nameaap Implantate AG
Device Count10
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
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
GS104042409049002 [Primary]
GS104042409391293 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JDWPIN, FIXATION, THREADED

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04042409049002]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2024-02-19
Device Publish Date2016-08-18

Devices Manufactured by aap Implantate AG

04042409042102 - NA2025-03-06 Direct measuring device for K-Wire, L 250
04042409451348 - NA2025-03-06 K-Wire with trocar point and thread, Ø2.4, L 250
04042409452000 - NA2025-03-06 Drill, Ø2.0, cannulated, I-Ø1.1, L 130, quick coupling
04042409452024 - NA2025-03-06 Drill, Ø2.0, cannulated, I-Ø1.1, L 130, quick coupling, Single Use
04042409452062 - NA2025-03-06 Drill, Ø2.5, cannulated, I-Ø1.3, L 145, quick coupling
04042409452086 - NA2025-03-06 Drill, Ø2.5, cannulated, I-Ø1.3, L 145, quick coupling, Single Use
04042409452123 - NA2025-03-06 Drill, Ø3.7, cannulated, I-Ø1.75, L 215, quick coupling
04042409452147 - NA2025-03-06 Drill, Ø3.7, cannulated, I-Ø1.75, L 215, quick coupling, Single Use

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.