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Inion FreedomScrew Instrumentation
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref IFS-3501Ref IFS-9022Ref IFS-9002Ref IFS-9021Ref IFS-9901Ref IFS-9012Ref IFS-9023Ref IFS-9053Ref IFS-9001
by Inion Oy
Identity
- Trade Name
- Inion FreedomScrew Instrumentation EUDAMEDInion FreedomScrew™ instrumentation EUDAMEDInion FreedomScrew instruments FDA UDI
- Generic Name
- Medical ruler, reusable FDA UDIFluted surgical drill bit, reusable FDA UDISurgical drill guide, reusable FDA UDISurgical screwdriver, reusable FDA UDI
- Device Name
- Inion Instruments EUDAMEDInion FreedomScrew instrument EUDAMEDInion FreedomScrew instrumentation EUDAMEDScale for Ø3.5 - 4.5 mm screws (INS-9111) FDA UDIDrill bit Ø2.5 mm FDA UDIDrill sleeve Ø2.5/3.5 mm, for Ø3.5 mm screws FDA UDIDrill sleeve Ø2.0/2.7 mm, for Ø2.7 mm screws FDA UDIHolding sleeve for Ø3.5 - 4.5 mm screws FDA UDIScrewdriver shaft, hex 3.5 mm, cannulated FDA UDIDrill sleeve Ø1.5/2.0 mm, for Ø2.0 mm screws FDA UDIScrewdriver shaft, hex 2.5 mm FDA UDI
- Model / Reference
- IFS-3501 EUDAMEDIFS-9022 EUDAMEDIFS-9002 EUDAMEDIFS-9021 EUDAMEDIFS-9901 EUDAMEDIFS-9012 EUDAMEDIFS-9023 EUDAMEDIFS-9053 EUDAMEDIFS-9001 EUDAMED1 FDA UDI
- Description
- Scale for Ø3.5 - 4.5 mm screws (INS-9111) FDA UDIDrill bit Ø2.5 mm FDA UDIDrill sleeve Ø2.5/3.5 mm, for Ø3.5 mm screws FDA UDIDrill sleeve Ø2.0/2.7 mm, for Ø2.7 mm screws FDA UDIHolding sleeve for Ø3.5 - 4.5 mm screws FDA UDIScrewdriver shaft, hex 3.5 mm, cannulated FDA UDIDrill sleeve Ø1.5/2.0 mm, for Ø2.0 mm screws FDA UDIScrewdriver shaft, hex 2.5 mm FDA UDI
Identifiers
- Catalog Number
- IFS-9053 FDA UDIIFS-3501 FDA UDIIFS-9023 FDA UDIIFS-9022 FDA UDIIFS-9012 FDA UDIIFS-9002 FDA UDIIFS-9021 FDA UDIIFS-9001 FDA UDI
- Primary DI / UDI-DI
- 06438408003837 EUDAMEDFDA UDI06438408003981 EUDAMEDFDA UDI06438408003943 EUDAMEDFDA UDI06438408003974 EUDAMEDFDA UDI06438408004124 EUDAMED06438408003967 EUDAMEDFDA UDI06438408003998 EUDAMEDFDA UDI06438408004087 EUDAMEDFDA UDI06438408003936 EUDAMEDFDA UDI
- Basic UDI-DI
- 6438408INION-IIA-INSTRUUR EUDAMEDB-06438408003981 EUDAMEDB-06438408003943 EUDAMED6438408INION-IR-INSTRUM9T EUDAMEDB-06438408003974 EUDAMEDB-06438408004124 EUDAMEDB-06438408003998 EUDAMEDB-06438408004087 EUDAMEDB-06438408003837 EUDAMEDB-06438408003967 EUDAMED6438408INION-IM-INSTRUM68 EUDAMEDB-06438408003936 EUDAMED
- Secondary DI
- M224IFS35019 EUDAMEDM224IFS90219 EUDAMEDM224IFS90129 EUDAMEDM224IFS90019 EUDAMEDM224IFS90029 EUDAMEDM224IFS90239 EUDAMEDM224IFS90229 EUDAMEDM224IFS90539 EUDAMED
- Direct Marketing DI
- 06438408003967 EUDAMED06438408004087 EUDAMED06438408003981 EUDAMED06438408003837 EUDAMED06438408003936 EUDAMED06438408003943 EUDAMED06438408003974 EUDAMED06438408003998 EUDAMED
- FDA Product Code
- LXH FDA UDIHTW FDA UDIFZX FDA UDIHXX FDA UDI
- EMDN Code
- L091001 INSTRUMENTS FOR INSERTION AND EXTRACTION OF MATERIALS FOR OSTEOSYNTHESIS, REUSABLE EUDAMEDV0402 CLINICAL USE TRAYS AND BOWLS EUDAMEDL091002 INSTRUMENTS FOR PROCESSING MATERIALS FOR OSTEOSYNTHESIS, REUSABLE EUDAMEDV0380 DEVICES WITH MEASURING FUNCTIONS - ACCESSORIES EUDAMED
- GMDN Term
- Medical ruler, reusable FDA UDIFluted surgical drill bit, reusable FDA UDISurgical drill guide, reusable FDA UDISurgical screwdriver, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I EUDAMEDFDA UDI
- 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
EUDAMEDEUDAMED
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 FreedomScrew Instrumentation by Inion Oy — Class IIa — 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-IIA-INSTRUUR | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 6438408INION-IIA-INSTRUUR | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Inion Oy
- EUDAMED SRN
- FI-MF-000000646
Sources (33)
- EUDAMED 7af6c88e-15ef-4558-9631-82e286030639 61 fields · synced Jul 27, 2026
- EUDAMED 6c7ffec5-a809-4812-bd85-ae53f35a86d2 61 fields · synced May 16, 2026
- EUDAMED 5dd615f8-975e-4513-8bd3-0a9d58d5d392 61 fields · synced May 17, 2026
- EUDAMED 27ee8f37-7f57-4da0-b21c-a61f540a4cac 61 fields · synced May 17, 2026
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- EUDAMED da475208-2615-4dab-bef3-396abc27fe15 61 fields · synced May 17, 2026
- EUDAMED df843781-89bd-4047-864e-caa6440ec25f 61 fields · synced May 17, 2026
- EUDAMED 5d496eec-4daa-4510-b7b8-09f631e6be74 61 fields · synced May 17, 2026
- EUDAMED 1ca32514-c12d-4ebd-8297-debc8ea596a1 61 fields · synced May 17, 2026
- EUDAMED 473c5e77-e3a1-4f01-a684-1f3cb6d7ba23 61 fields · synced May 18, 2026
- EUDAMED 013d060f-b3e4-4283-84e3-1dd97ece17a9 61 fields · synced May 18, 2026
- EUDAMED 8808f064-5570-4f1f-8898-c33bcb2d3e77 61 fields · synced May 18, 2026
- EUDAMED 6c4823e8-b04e-4d46-aeb0-f9b0e1ec8f2e 61 fields · synced May 19, 2026
- EUDAMED d9560f6e-47ae-4ed6-afb7-4108624dfb2c 61 fields · synced May 19, 2026
- EUDAMED 61b4b041-a651-4e9f-96ba-c8c3eedabad4 61 fields · synced May 19, 2026
- EUDAMED de86da26-0463-4ed2-85ce-313dcdaae740 61 fields · synced May 19, 2026
- EUDAMED cc342325-f743-4538-9c60-e518019ee584 61 fields · synced May 19, 2026
- FDA UDI f6a2f168-713b-496f-b9ef-5d940b6678e6 34 fields · synced May 24, 2026
- FDA UDI 194cd852-c648-452e-8f7c-51a03a5ca881 34 fields · synced May 25, 2026
- FDA UDI 40672cf4-9b21-4ddd-83e2-96cd5b3c5362 34 fields · synced May 29, 2026
- FDA UDI f320daae-67fd-4058-a6ba-0a16c389f9cc 34 fields · synced May 29, 2026
- FDA UDI 905e66b4-0bf7-484b-bda1-a9ad9536b55a 34 fields · synced May 30, 2026
- FDA UDI d289107c-0ea2-4d6d-ad64-9947cca2d4a5 34 fields · synced May 30, 2026
- FDA UDI 1dbe5bbc-eedd-440e-b6d5-2c2e4f7e1540 34 fields · synced May 30, 2026
- FDA UDI 4c3465c2-1d8d-4972-9107-b5bbf311377b 34 fields · synced May 30, 2026
- EUDAMED 54985022-eaa7-4ea3-bb4a-53c999333728 61 fields · synced Jul 9, 2026
- EUDAMED 3151061d-4ec7-46f2-bee8-9e89c0ac7072 61 fields · synced Jul 10, 2026
- EUDAMED fe7f0df4-752c-42d1-a0e1-e3a0d892d816 61 fields · synced Jul 12, 2026
- EUDAMED 256fc82f-3261-4319-b962-9001dbb4caad 61 fields · synced Jul 14, 2026
- EUDAMED 9e460d31-a7d8-4d65-90d8-637dd5e24b43 61 fields · synced Jul 15, 2026
- EUDAMED 21b261b1-2ebb-4fb2-bba8-d6b8b3a90412 61 fields · synced Jul 16, 2026
- EUDAMED f6d5a787-9578-4e2d-bbf1-aad253977d50 61 fields · synced Jul 23, 2026
- EUDAMED faf1b728-f82d-4c31-b819-8d0a855e23a0 61 fields · synced Jul 27, 2026