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Kirschner wire
EUDAMEDFDA UDIFDA 510(k)Class IIb (EU MDR)
Ref K20 NS070510(k) K153204Ref K10 NS100Ref K10 NS150Ref K20 NS150Ref K13 SS070Ref K11 NS071Ref K20 NS100Ref K13 SS100Ref K21 NS312Ref K10 NS102Ref K10 SS071
by In2Bones SAS
Identity
- Trade Name
- Kirschner wire EUDAMEDFDA UDI
- Generic Name
- Orthopaedic bur, reusable FDA UDIOrthopaedic bone pin, non-bioabsorbable FDA UDI
- Device Name
- Kirschner wire EUDAMEDInstruments, orthopaedic surgeries of the upper and lower extremities EUDAMEDKIRSCHNER WIRE NS DIAM 1.0 MM LENGTH 100 MM 2 SHARP TIPS FDA UDIPACK 3 KWIRES DIAM 0.8 MM LG 70 MM 1 SHARP TIP STERILE FDA UDIKIRSCHNER WIRE NS DIAM 0.8 MM LENGTH 70 MM 2 SHARP TIPS FDA UDI10 KWIRES DIAM 1.0 MM LENGTH 70 MM 1 SHARP END FDA UDIPACK 3 KWIRES DIAM 1.0 MM LG 100 MM 1 SHARP TIP STERILE FDA UDIK-WIRE NO STERILE DIAM 2.0 MM LENGTH 100 MM 1 SHARP TIP FDA UDIK-WIRE DIAM 1.0 MM LENGTH 70 MM 1 SHARP TIP STERILE FDA UDI10 KIRSCHNER WIRES NS DIA. 1.2 MM LENGTH 300 MM 2 SHARP TIPS FDA UDIK-WIRE NO STERILE DIAM 1.6 MM LENGTH 150 MM 1 SHARP TIP FDA UDIK-WIRE NO STERILE DIAM 1.0 MM LENGTH 100 MM 1 SHARP TIP FDA UDIKIRSCHNER WIRE NS DIAM 1.6 MM LENGTH 150 MM 2 SHARP TIPS FDA UDI
- Model / Reference
- K20 NS070 EUDAMEDFDA UDIK10 NS100 EUDAMEDFDA UDIK10 NS150 EUDAMEDFDA UDIK20 NS150 EUDAMEDFDA UDIK13 SS070 EUDAMEDFDA UDIK11 NS071 EUDAMEDFDA UDIK20 NS100 EUDAMEDFDA UDIK13 SS100 EUDAMEDFDA UDIK21 NS312 EUDAMEDFDA UDIK10 NS102 EUDAMEDFDA UDIK10 SS071 EUDAMEDFDA UDI
- Description
- KIRSCHNER WIRE NS DIAM 1.0 MM LENGTH 100 MM 2 SHARP TIPS FDA UDIPACK 3 KWIRES DIAM 0.8 MM LG 70 MM 1 SHARP TIP STERILE FDA UDIKIRSCHNER WIRE NS DIAM 0.8 MM LENGTH 70 MM 2 SHARP TIPS FDA UDI10 KWIRES DIAM 1.0 MM LENGTH 70 MM 1 SHARP END FDA UDIPACK 3 KWIRES DIAM 1.0 MM LG 100 MM 1 SHARP TIP STERILE FDA UDIK-WIRE NO STERILE DIAM 2.0 MM LENGTH 100 MM 1 SHARP TIP FDA UDIK-WIRE DIAM 1.0 MM LENGTH 70 MM 1 SHARP TIP STERILE FDA UDI10 KIRSCHNER WIRES NS DIA. 1.2 MM LENGTH 300 MM 2 SHARP TIPS FDA UDIK-WIRE NO STERILE DIAM 1.6 MM LENGTH 150 MM 1 SHARP TIP FDA UDIK-WIRE NO STERILE DIAM 1.0 MM LENGTH 100 MM 1 SHARP TIP FDA UDIKIRSCHNER WIRE NS DIAM 1.6 MM LENGTH 150 MM 2 SHARP TIPS FDA UDI
Identifiers
- Catalog Number
- K20 NS100 FDA UDIK13 SS070 FDA UDIK20 NS070 FDA UDIK11 NS071 FDA UDIK13 SS100 FDA UDIK10 NS102 FDA UDIK10 SS071 FDA UDIK21 NS312 FDA UDIK10 NS150 FDA UDIK10 NS100 FDA UDIK20 NS150 FDA UDI
- Primary DI / UDI-DI
- 03760225715451 EUDAMEDFDA UDI03760225711583 EUDAMEDFDA UDI03760225711590 EUDAMEDFDA UDI03760225715499 EUDAMEDFDA UDI03760225714874 EUDAMEDFDA UDI03760225712276 EUDAMEDFDA UDI03760225718889 EUDAMEDFDA UDI03760225714898 EUDAMEDFDA UDI03760225715628 EUDAMEDFDA UDI03760225714102 EUDAMEDFDA UDI03760225714850 EUDAMEDFDA UDI
- Basic UDI-DI
- B-03760225715451 EUDAMEDB-03760225711583 EUDAMEDB-03760225711590 EUDAMED37013376410773 EUDAMEDB-03760225714874 EUDAMEDB-03760225712276 EUDAMEDB-03760225718889 EUDAMEDB-03760225714898 EUDAMEDB-03760225715628 EUDAMEDB-03760225714102 EUDAMEDB-03760225714850 EUDAMED
- 510(k) Number
- K153204 FDA UDI
- FDA Product Code
- HTY FDA UDIFZX FDA UDI
- EMDN Code
- P09120301 KIRSCHNER BONE WIRES EUDAMEDL091199 ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Orthopaedic bur, reusable FDA UDIOrthopaedic bone pin, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass I 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
No
EUDAMEDFDA UDIEUDAMEDFDA UDI
Single Use
No
FDA UDIFDA UDI
Implantable
Yes
EUDAMEDFDA UDIEUDAMEDFDA UDI
Reusable
No
EUDAMEDEUDAMED
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
No
FDA UDIFDA UDI
Manufacturing Date
Yes
FDA UDIFDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 0.8 Millimeter FDA UDILength — 70 Millimeter FDA UDIOuter Diameter — 1.0 Millimeter FDA UDILength — 100 Millimeter FDA UDIOuter Diameter — 2.0 Millimeter FDA UDIOuter Diameter — 1.2 Millimeter FDA UDILength — 300 Millimeter FDA UDILength — 150 Millimeter FDA UDIOuter Diameter — 1.6 Millimeter FDA UDI
Kirschner wire by In2Bones SAS — Class IIb — MDR, FDA_510K, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-03760225715451 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K153204 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-03760225715451 | Class IIb | Active |
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Manufacturer
- Manufacturer
- In2Bones SAS
- EUDAMED SRN
- FR-MF-000005246
Sources (33)
- EUDAMED d3e1e79b-ae6c-4a22-aa4c-ea9986298c0d 85 fields · synced Sep 17, 2026
- EUDAMED 458b6b63-0564-4cbc-bae5-e1a19c2f43de 61 fields · synced May 16, 2026
- EUDAMED c1e0c35f-f110-4c32-8bb8-0b9fb04773a9 61 fields · synced May 16, 2026
- EUDAMED 35d4a8fc-562e-4fef-acd8-d0c35d8af371 61 fields · synced May 17, 2026
- EUDAMED 3b44ea14-9bfd-4af8-9f72-7fadcdf4e4bf 61 fields · synced May 17, 2026
- EUDAMED 1f3b912d-67eb-4f5e-8f4b-a56632483049 61 fields · synced May 18, 2026
- EUDAMED cf3cab8c-6417-4236-99eb-322cc0ded5d1 61 fields · synced May 18, 2026
- EUDAMED d486b258-6eb8-4fc4-a9ed-67a46b49feab 61 fields · synced May 18, 2026
- EUDAMED c90028f8-02dc-44af-90ab-7bca6bb6e25d 61 fields · synced May 18, 2026
- EUDAMED 85298f1a-9586-4d53-8f3e-d46e604adab4 61 fields · synced May 19, 2026
- EUDAMED ac023583-50ba-49fb-8c74-6d1e326827a8 61 fields · synced May 19, 2026
- FDA UDI 0ce6c5b9-0a3c-4e13-83f4-1ef5004519c7 36 fields · synced May 29, 2026
- FDA UDI a7190070-a1d0-4182-85b0-a887e0a1eb3d 37 fields · synced May 29, 2026
- FDA UDI 9596c986-ecf8-4c59-8cd3-98ea47f5113d 37 fields · synced May 30, 2026
- FDA UDI 696f884e-8dde-489b-bd0f-6654f5e6d991 37 fields · synced May 30, 2026
- FDA UDI 0a8c47ed-9121-40bd-84bc-c17220189162 37 fields · synced May 30, 2026
- FDA UDI b708a21e-8d25-4133-aaef-ee66bf0b48e5 37 fields · synced May 30, 2026
- FDA UDI 6cbe402b-0129-4cc2-856b-b651022f7704 37 fields · synced May 30, 2026
- FDA UDI c7d78742-bf8b-4baf-a387-752e99b8903a 37 fields · synced May 30, 2026
- FDA UDI 87d4dbde-35d5-4a57-80f2-f4eaefa4dc09 37 fields · synced May 30, 2026
- FDA UDI 6237dcaa-9ae1-4b7e-b694-0c4bb0dfee97 37 fields · synced May 30, 2026
- FDA UDI 0580c8f8-76c7-4a79-be0a-c55450d25929 37 fields · synced May 30, 2026
- EUDAMED ac3d581b-9a4e-4504-9372-f26748d53786 61 fields · synced Jun 20, 2026
- EUDAMED 305483c8-5ee5-4ea2-bd47-95d5ff7e19f0 61 fields · synced Jul 9, 2026
- EUDAMED bd593e40-4ec3-470d-835a-c7442ac7a715 61 fields · synced Jul 9, 2026
- EUDAMED 7a888c9e-de84-4ab3-96c9-3982e738c4fa 61 fields · synced Jul 9, 2026
- EUDAMED 1aac13a7-0e29-487d-84be-ff94d97feba4 61 fields · synced Jul 10, 2026
- EUDAMED dc009740-9e64-4d51-97a8-08d2d57d77a6 61 fields · synced Jul 15, 2026
- EUDAMED 29d10ab6-1868-4e29-afc5-37294f28fa13 61 fields · synced Jul 15, 2026
- EUDAMED 7c333040-62af-4943-904f-4299f7dff3ed 61 fields · synced Jul 17, 2026
- EUDAMED 0ccff514-43c1-41a4-b98e-e93eab728605 61 fields · synced Jul 20, 2026
- EUDAMED a83334c2-cf99-4617-b294-11102f6dffa6 61 fields · synced Sep 17, 2026
- FDA 510(k) K153204 1 fields · synced May 18, 2026