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Inion S-1 Instrumentation
EUDAMEDFDA UDIClass I (EU MDR)
Ref INS-9553Ref INS-9541Ref ACC-9828Ref ACC-9825Ref INS-9548Ref INS-9543Ref INS-9527Ref INS-9540Ref INS-9550Ref ACC-9824Ref INS-9554Ref INS-9542Ref ACC-9826Ref INS-9549
by Inion Oy
Identity
- Trade Name
- Inion S-1 Instrumentation EUDAMEDInion S-1™ Instrumentation EUDAMEDInion SPINE instrumentation FDA UDI
- Generic Name
- Surgical screwdriver, reusable FDA UDIFluted surgical drill bit, reusable FDA UDISurgical drill guide, reusable FDA UDI
- Device Name
- Inion Instruments EUDAMEDInion S-1 Instruments EUDAMEDInion S-1 Instrumentation EUDAMEDScrew removal instrument FDA UDIDrill bit 3.7 mm with stop for 14 mm screw FDA UDIDrill bit 3.7 mm with stop for 16 mm screw FDA UDIDrill bit 4.2 mm with stop for 12 mm screw FDA UDIDrill guide, single FDA UDIDrill bit 3.7 mm with stop for 12 mm screw FDA UDI
- Model / Reference
- INS-9553 EUDAMEDINS-9541 EUDAMEDACC-9828 EUDAMEDACC-9825 EUDAMEDINS-9548 EUDAMEDINS-9543 EUDAMEDINS-9527 EUDAMEDINS-9540 EUDAMEDINS-9550 EUDAMEDACC-9824 EUDAMEDINS-9554 EUDAMEDINS-9542 EUDAMEDACC-9826 EUDAMEDINS-9549 EUDAMED1 FDA UDI
- Description
- Screw removal instrument FDA UDIDrill bit 3.7 mm with stop for 14 mm screw FDA UDIDrill bit 3.7 mm with stop for 16 mm screw FDA UDIDrill bit 4.2 mm with stop for 12 mm screw FDA UDIDrill guide, single FDA UDIDrill bit 3.7 mm with stop for 12 mm screw FDA UDI
Identifiers
- Catalog Number
- INS-9553 FDA UDIINS-9541 FDA UDIINS-9542 FDA UDIINS-9543 FDA UDIINS-9554 FDA UDIINS-9540 FDA UDI
- Primary DI / UDI-DI
- 06438408005022 EUDAMEDFDA UDI06438408004902 EUDAMEDFDA UDI06438408004803 EUDAMED06438408004773 EUDAMED06438408004971 EUDAMED06438408004926 EUDAMEDFDA UDI06438408004889 EUDAMED06438408004896 EUDAMEDFDA UDI06438408004995 EUDAMED06438408004766 EUDAMED06438408005039 EUDAMEDFDA UDI06438408004919 EUDAMEDFDA UDI06438408004780 EUDAMED06438408004988 EUDAMED
- Basic UDI-DI
- 6438408INION-IR-INSTRUM9T EUDAMED6438408INION-IIA-INSTRUUR EUDAMEDB-06438408004773 EUDAMEDB-06438408004971 EUDAMEDB-06438408004926 EUDAMEDB-06438408004889 EUDAMEDB-06438408004896 EUDAMEDB-06438408004902 EUDAMEDB-06438408004766 EUDAMEDB-06438408004919 EUDAMEDB-06438408004995 EUDAMEDB-06438408004780 EUDAMEDB-06438408005039 EUDAMEDB-06438408004803 EUDAMEDB-06438408004988 EUDAMED
- Secondary DI
- M224INS95539 EUDAMEDM224INS95419 EUDAMEDM224ACC982810 EUDAMEDM224INS955010 EUDAMEDM224INS954810 EUDAMEDM224INS95549 EUDAMEDM224ACC982610 EUDAMEDM224INS954910 EUDAMEDM224INS952710 EUDAMEDM224INS95429 EUDAMEDM224ACC982410 EUDAMEDM224ACC982510 EUDAMEDM224INS95409 EUDAMEDM224INS95439 EUDAMED
- Direct Marketing DI
- 06438408005022 EUDAMED06438408004780 EUDAMED06438408004902 EUDAMED06438408004803 EUDAMED06438408004896 EUDAMED06438408004995 EUDAMED06438408004988 EUDAMED06438408004766 EUDAMED06438408004926 EUDAMED06438408004773 EUDAMED06438408004971 EUDAMED06438408005039 EUDAMED
- FDA Product Code
- HXX FDA UDIHTW FDA UDIFZX FDA UDI
- EMDN Code
- L091001 INSTRUMENTS FOR INSERTION AND EXTRACTION OF MATERIALS FOR OSTEOSYNTHESIS, REUSABLE EUDAMEDL091002 INSTRUMENTS FOR PROCESSING MATERIALS FOR OSTEOSYNTHESIS, REUSABLE EUDAMEDL098003 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY TAPS, REUSABLE EUDAMED
- GMDN Term
- Surgical screwdriver, reusable FDA UDIFluted surgical drill bit, reusable FDA UDISurgical drill guide, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDIClass IIa EUDAMED
- Regulation Number
- 888.4540 FDA UDI878.4800 FDA UDI
- Market of Registration
- Finland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
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
Yes
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
Inion S-1 Instrumentation by Inion Oy — Class I — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 6438408INION-IR-INSTRUM9T | Class I | Active |
| EUDAMED | European Union | CE/MDR | 6438408INION-IR-INSTRUM9T | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Inion Oy
- EUDAMED SRN
- FI-MF-000000646
Sources (46)
- EUDAMED 6b1b70d1-ed3a-426a-a308-1a0c5d9ac6c9 61 fields · synced Aug 2, 2026
- EUDAMED 138757ed-c3a0-42a6-a3d9-7b2a397f13ab 61 fields · synced May 11, 2026
- EUDAMED 6c611e7c-4e5c-40a7-8831-4364137b0439 61 fields · synced May 16, 2026
- EUDAMED 96ccec74-d637-432b-9724-5223305d6416 61 fields · synced May 17, 2026
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- EUDAMED 4f84e361-a90b-48c9-88ff-8edff4135ca9 61 fields · synced May 17, 2026
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- EUDAMED 1f6ba02b-a123-41df-8b7d-6da408849af3 61 fields · synced May 17, 2026
- EUDAMED 22ca88fd-73d2-4a98-8bf3-9c66b74e10e5 61 fields · synced May 17, 2026
- EUDAMED f0564ea1-ac0d-4ae2-ad24-ce4aa8481fc3 61 fields · synced May 17, 2026
- EUDAMED cc1f867f-4fd5-473c-8d57-eea4fa90b1a7 61 fields · synced May 17, 2026
- EUDAMED d6b3d0b3-01b4-49f9-a1af-15b06b52089a 61 fields · synced May 17, 2026
- EUDAMED 205b21f0-945f-479c-b34b-b97269633a45 61 fields · synced May 18, 2026
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- EUDAMED dec0f727-9e56-4731-87f5-2050960feb7e 61 fields · synced May 18, 2026
- EUDAMED afc7571f-38ee-4ebb-87ac-b05d508f9c1a 61 fields · synced May 18, 2026
- EUDAMED f7e19225-2064-44c5-bbd5-f9da6c17edce 61 fields · synced May 18, 2026
- EUDAMED f9d3cd00-8e04-486c-b33a-c5d8b6a89974 61 fields · synced May 18, 2026
- EUDAMED 3632368a-6f57-4f14-a2b0-91a5632c2b38 61 fields · synced May 18, 2026
- EUDAMED c4b38ef0-8978-4dee-baf4-0b1471b13726 61 fields · synced May 18, 2026
- EUDAMED dbdf98a3-d966-4232-a270-caaea2e53492 61 fields · synced May 19, 2026
- EUDAMED 9e6ddbb4-c1ab-48e6-8f74-bb76baf2b048 61 fields · synced May 19, 2026
- EUDAMED 9b23daa9-fc5d-4518-a438-39bba0087752 61 fields · synced May 19, 2026
- EUDAMED 97aedea7-5223-4ea0-8eac-ee74883db6ab 61 fields · synced May 19, 2026
- EUDAMED 4eef97d9-86c0-47ce-a034-70e39cda1d50 61 fields · synced May 19, 2026
- EUDAMED b98672f8-210b-46d9-8647-49d589b3757b 61 fields · synced May 19, 2026
- FDA UDI 93bc465b-0242-46cb-a6a0-5a1e5c663db7 34 fields · synced May 25, 2026
- FDA UDI b35cc56d-53ed-423d-b362-6ba8a2f31e4f 34 fields · synced May 30, 2026
- FDA UDI 546f72fb-1b3b-46d7-a041-ebd5419de455 34 fields · synced May 30, 2026
- FDA UDI 28a676fa-983b-4d58-8b14-bcaaf7913d2d 34 fields · synced May 30, 2026
- FDA UDI 948d66d1-3549-47a0-bf3a-3f65fe4509b9 34 fields · synced May 30, 2026
- FDA UDI bc4b4a10-e89d-4740-bc12-9efb65f89c20 34 fields · synced May 30, 2026
- EUDAMED 8640cbac-e8e4-40fb-afcb-7d2bca6216e3 61 fields · synced Jun 20, 2026
- EUDAMED 20d5869f-c854-452c-8ad0-c1cd7b1dcdcd 61 fields · synced Jul 9, 2026
- EUDAMED 003eb290-ef28-457e-9487-b85a7c837997 61 fields · synced Jul 9, 2026
- EUDAMED 0ee1d6b8-dedc-4661-a50e-0ded7de7fc28 61 fields · synced Jul 10, 2026
- EUDAMED a9a2c772-25e4-458b-89bf-772e93e4e9e5 61 fields · synced Jul 12, 2026
- EUDAMED 1b461436-09f7-4e9b-a0b8-779abd34f793 61 fields · synced Jul 12, 2026
- EUDAMED e6618940-6e1d-4966-bb0a-716c562928e9 61 fields · synced Jul 14, 2026
- EUDAMED ec05a1bb-f32f-4cce-a101-4728c6890c39 61 fields · synced Jul 15, 2026
- EUDAMED 1eb9aec2-5976-4fee-8398-2d06d69f78d6 61 fields · synced Jul 15, 2026
- EUDAMED 9f69650e-df9d-44e0-bd22-884793f0ae56 61 fields · synced Jul 20, 2026
- EUDAMED 91a32b10-377c-4059-86f2-894909a6ea0b 61 fields · synced Jul 24, 2026
- EUDAMED f4f97d19-45a7-4d28-8078-8dff4557ccf2 61 fields · synced Jul 27, 2026
- EUDAMED 679c8974-ad67-4771-81bc-16851cf7f271 61 fields · synced Aug 2, 2026