Identity
- Trade Name
- 0.6 K-Wire, Trocar, 100mm, 1/Pkg EUDAMEDAPTUS FDA UDI
- Generic Name
- Orthopaedic bone wire FDA UDI
- Device Name
- Bone screws (sterile, non-sterile) EUDAMED0.6 K-Wire, Trocar, 100mm, 1/Pkg FDA UDI
- Model / Reference
- A-5040.90/1 EUDAMEDFDA UDI
- Description
- 0.6 K-Wire, Trocar, 100mm, 1/Pkg FDA UDI
Identifiers
- Catalog Number
- A-5040.90/1 FDA UDI
- Primary DI / UDI-DI
- 07630037864066 EUDAMEDFDA UDI
- Basic UDI-DI
- 76300378022PA EUDAMED
- 510(k) Number
- K202589 FDA UDI
- FDA Product Code
- HTY FDA UDI
- EMDN Code
- P09120699 BONE FIXATION SCREWS, TENDON AND LIGAMENT SYNTHESIS SCREWS - OTHER EUDAMED
- GMDN Term
- Orthopaedic bone wire FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3040 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Sutures
Yes
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic bone wire
Aptus by Medartis Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic bone wire.
- mahe medical GmbH — mahe medical gmbh · Class II
- SALVATION™ — WRIGHT MEDICAL TECHNOLOGY, INC. · Class I
- De Soutter Medical — De Soutter Medical, Ltd. · Class I
- SMOOTH K-WIRE, DOUBLE END TROCAR POINT — Biomet Orthopedics, Inc. · Class II
- mahe medical GmbH — mahe medical gmbh · Class II
- OIC Variable Angle Small Fragment Locking Plate System — ORTHOPAEDIC IMPLANT COMPANY, THE · Class II
- THP™ Hip Fracture Plating System — Biomet Orthopedics, Inc. · Class II
- gSource — GSOURCE, LLC. · Class II
Cleared under the same submission
K202589 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
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
- Medartis Inc.
Sources (2)
- FDA UDI 791f2bc6-6d80-4801-b7ea-45d46fc7d267 35 fields · synced Jun 20, 2026
- EUDAMED 808fa7c9-9280-4ae8-9e7a-62f3e9400795 61 fields · synced Jun 20, 2026