K-Wire w/ thread, Trocar w. 15 mm thread, round 1.5 mm x 150 mm
FDA UDIEUDAMEDClass II (US FDA UDI)
by Joimax, Inc.
Identity
- Trade Name
- K-Wire w/ thread, Trocar w. 15 mm thread, round 1.5 mm x 150 mm FDA UDI
- Generic Name
- Electromagnetic surgical navigation device tracking system FDA UDI
- Device Name
- K-Wire w/ thread, Trocar w. 15mm thread, round 1.5 mm x 150 mm EUDAMED
- Model / Reference
- JKW1515 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04250337118015 EUDAMEDFDA UDI
- Basic UDI-DI
- 42503371INNAKWDB EUDAMED
- Direct Marketing DI
- 04250337118015 EUDAMED
- 510(k) Number
- K192663 FDA UDI
- FDA Product Code
- OLO FDA UDI
- EMDN Code
- L1199 NEUROSURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Electromagnetic surgical navigation device tracking system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 882.4560 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Electromagnetic surgical navigation device tracking system
K-Wire w/ thread, Trocar w. 15 mm thread, round 1.5 mm x 150 mm by Joimax, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED
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Cleared under the same submission
K192663 also covers:
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- Intracs® — JOIMAX, INC.
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- Joimax® Intracs® EM Patient Mapper - AP — JOIMAX, INC.
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Joimax, Inc.
Sources (2)
- FDA UDI 10a3522f-aae8-4610-9213-c8e9bc1cf304 33 fields · synced Oct 6, 2026
- EUDAMED 07cc5dbc-db80-4480-834c-af8d1c283444 61 fields · synced Oct 6, 2026