Identity
- Trade Name
- Kirschner wire EUDAMEDFDA UDI
- Generic Name
- Orthopaedic bone pin, non-bioabsorbable FDA UDI
- Device Name
- Kirschner wire EUDAMEDK-WIRE DIAM 1.0 MM LENGTH 100 MM 1 SHARP TIP STERILE FDA UDI
- Model / Reference
- K10 SS100 EUDAMEDFDA UDI
- Description
- K-WIRE DIAM 1.0 MM LENGTH 100 MM 1 SHARP TIP STERILE FDA UDI
Identifiers
- Catalog Number
- K10 SS100 FDA UDI
- Primary DI / UDI-DI
- 03760225714867 EUDAMEDFDA UDI
- Basic UDI-DI
- B-03760225714867 EUDAMED
- 510(k) Number
- K153204 FDA UDI
- FDA Product Code
- HTY FDA UDIFZX FDA UDI
- EMDN Code
- P09120301 KIRSCHNER BONE WIRES EUDAMED
- GMDN Term
- Orthopaedic bone pin, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3040 FDA UDI878.4800 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 1.0 Millimeter FDA UDILength — 100 Millimeter FDA UDI
Category: Orthopaedic bone pin, non-bioabsorbable
Kirschner wire by In2Bones SAS — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic bone pin, non-bioabsorbable.
- Steinmann Pins, K-Wire, smooth — Gebr. Brasseler GmbH & Co. KG · Class II
- KW03-310-18.A — newbox medical GmbH · Class IIb
- Steinmann Pins, K-Wire, smooth — Gebr. Brasseler GmbH & Co. KG · Class II
- IlluminOss — ILLUMINOSS MEDICAL INC. · Class II
- XtraFix® External Fixation System — Zimmer, Inc. · Class II
- CALIBRATED GUIDE WIRE, THREADED TROCAR POINT — Biomet Orthopedics, Inc. · Class II
- TRAUMA FIXATION SYSTEMS — Biomet Orthopedics, Inc. · Class II
- SMART TSF — Smith & Nephew, Inc. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-03760225714867 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- In2Bones SAS
- EUDAMED SRN
- FR-MF-000005246
Sources (2)
- EUDAMED 3f5e44c9-fcf1-43af-887c-d6b34a4a0aa9 61 fields · synced Jun 8, 2026
- FDA UDI f54b8580-d669-478f-a2e7-9d6b41ad75f8 37 fields · synced May 30, 2026