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Inion CompressOn screw instrumentation
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref IFS-6003Ref IFS-4513Ref IFS-9026Ref IFS-9065Ref IFS-5003Ref IFS-4518Ref IFS-9064Ref IFS-9006Ref IFS-9045Ref IFS-9063
by Inion Oy
Identity
- Trade Name
- Inion CompressOn screw instrumentation EUDAMEDInion CompressOn™ Instrument FDA UDI
- Generic Name
- Surgical depth gauge, reusable FDA UDISurgical screwdriver, reusable FDA UDIBone tap, reusable FDA UDIFluted surgical drill bit, reusable FDA UDISurgical drill guide, reusable FDA UDI
- Device Name
- Inion CompressOn Screw instrumentation EUDAMEDInion Instruments EUDAMEDDepth gauge for 150 mm K-wire FDA UDIScrewdriver shaft, T25 FDA UDIDrill tap Ø 4.5 Cannulated, short FDA UDIDrill Ø 4.2 mm, cannulated FDA UDIDrill sleeve Ø4.2/6.0 mm, for Ø 6.0 mm screws FDA UDIK-wire Ø 1.6x150 mm FDA UDIDrill Ø 3.2 Cannulated, short FDA UDIK-wire Ø 1.25x150 mm FDA UDIDrill Ø 3.7 mm, cannulated FDA UDI
- Model / Reference
- IFS-6003 EUDAMEDIFS-4513 EUDAMEDIFS-9026 EUDAMEDIFS-9065 EUDAMEDIFS-5003 EUDAMEDIFS-4518 EUDAMEDIFS-9064 EUDAMEDIFS-9006 EUDAMEDIFS-9045 EUDAMEDIFS-9063 EUDAMED1 FDA UDI
- Description
- Depth gauge for 150 mm K-wire FDA UDIScrewdriver shaft, T25 FDA UDIDrill tap Ø 4.5 Cannulated, short FDA UDIDrill Ø 4.2 mm, cannulated FDA UDIDrill sleeve Ø4.2/6.0 mm, for Ø 6.0 mm screws FDA UDIK-wire Ø 1.6x150 mm FDA UDIDrill Ø 3.2 Cannulated, short FDA UDIK-wire Ø 1.25x150 mm FDA UDIDrill Ø 3.7 mm, cannulated FDA UDI
Identifiers
- Catalog Number
- IFS-9045 FDA UDIIFS-9006 FDA UDIIFS-4518 FDA UDIIFS-6003 FDA UDIIFS-9026 FDA UDIIFS-9065 FDA UDIIFS-4513 FDA UDIIFS-9064 FDA UDIIFS-5003 FDA UDI
- Primary DI / UDI-DI
- 06438408008054 EUDAMEDFDA UDI06438408009709 EUDAMEDFDA UDI06438408008115 EUDAMEDFDA UDI06438408008931 EUDAMEDFDA UDI06438408008047 EUDAMEDFDA UDI06438408009723 EUDAMEDFDA UDI06438408008924 EUDAMEDFDA UDI06438408008016 EUDAMEDFDA UDI06438408008900 EUDAMEDFDA UDI06438408012082 EUDAMED
- Basic UDI-DI
- B-06438408008054 EUDAMEDB-06438408009709 EUDAMED6438408INION-IIA-INSTRUUR EUDAMEDB-06438408008115 EUDAMEDB-06438408008931 EUDAMEDB-06438408008047 EUDAMEDB-06438408009723 EUDAMEDB-06438408008924 EUDAMED6438408INION-IR-INSTRUM9T EUDAMEDB-06438408008016 EUDAMEDB-06438408008900 EUDAMED6438408INION-IRM-INSTRUAF EUDAMED
- Direct Marketing DI
- 06438408008016 EUDAMED06438408008115 EUDAMED06438408008900 EUDAMED06438408009709 EUDAMED06438408009723 EUDAMED06438408008047 EUDAMED06438408008054 EUDAMED
- 510(k) Number
- K203105 FDA UDI
- FDA Product Code
- HTJ FDA UDIHWC FDA UDIHTW FDA UDIFZX FDA UDILXH FDA UDI
- EMDN Code
- L091001 INSTRUMENTS FOR INSERTION AND EXTRACTION OF MATERIALS FOR OSTEOSYNTHESIS, REUSABLE EUDAMEDL098003 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY TAPS, REUSABLE EUDAMEDP091399 ORTHOPAEDIC IMPLANT INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Surgical depth gauge, reusable FDA UDISurgical screwdriver, reusable FDA UDIBone tap, reusable FDA UDIFluted surgical drill bit, reusable FDA UDISurgical drill guide, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I EUDAMEDFDA UDIClass II FDA UDI
- Regulation Number
- 888.4300 FDA UDI888.3040 FDA UDI888.4540 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 UDIFDA 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 CompressOn screw instrumentation by Inion Oy — Class IIa — FDA_510K, MDD, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K203105 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06438408008054 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | B-06438408008054 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Inion Oy
- EUDAMED SRN
- FI-MF-000000646
Sources (38)
- EUDAMED 2bebe9e4-99ab-489e-b59c-38179ad21a4d 61 fields · synced Oct 1, 2026
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- EUDAMED 6b75c41c-bed8-42d0-b169-1e024bd4d9bc 61 fields · synced May 17, 2026
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- EUDAMED 6294dfc3-8b98-4aaf-b65f-7926f97100ed 61 fields · synced May 17, 2026
- EUDAMED 20df12d2-23e5-4f3d-977c-4584abcf0072 61 fields · synced May 17, 2026
- EUDAMED 87223550-5404-4026-bfe0-f190b6f25029 61 fields · synced May 17, 2026
- EUDAMED 2fb1c3bf-d25d-44ef-b1f2-4107f23ad38e 61 fields · synced May 17, 2026
- EUDAMED be66782d-f232-420f-a095-bc392979ada5 61 fields · synced May 17, 2026
- EUDAMED c9d872c6-51ed-4769-83f5-f303a98e72e3 61 fields · synced May 18, 2026
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- EUDAMED 53323af2-8e99-437f-be96-c683facf6ce9 61 fields · synced May 19, 2026
- EUDAMED 96903728-df22-4368-badd-597a43d53bc9 61 fields · synced May 19, 2026
- EUDAMED 6e381c35-b14d-4160-b83c-ecac5954a284 61 fields · synced May 19, 2026
- EUDAMED 6695974d-bb1b-44fd-b17d-de076c3e0e21 61 fields · synced May 19, 2026
- FDA UDI e910dc63-70ce-410c-af45-b0b4802c4e75 34 fields · synced May 24, 2026
- FDA UDI 5764fb59-3e71-4b8a-8836-d2765d5391ab 35 fields · synced May 29, 2026
- FDA UDI 8168a867-74c8-46ee-b89e-a61a4a71bbea 35 fields · synced May 29, 2026
- FDA UDI c3bd9d10-0bfa-46cb-b2b5-e9bd1a1d147a 34 fields · synced May 30, 2026
- FDA UDI f2742bbf-1e1a-4e2f-a438-675eee54ee8c 34 fields · synced May 30, 2026
- FDA UDI ce5ad382-87b0-452a-ba51-88bcc5e627e2 34 fields · synced May 30, 2026
- FDA UDI 5f42812d-f8de-4a18-b7cf-f1a2624ecfb3 34 fields · synced May 30, 2026
- FDA UDI a8fe3b5a-9a9b-4428-bb4b-a367aa9eb286 34 fields · synced May 30, 2026
- FDA UDI 50dfd4ea-24dc-4ffd-a383-e3025780b397 34 fields · synced May 30, 2026
- EUDAMED 85fb7d7a-546c-4243-a799-1409f237fa3d 61 fields · synced Jul 10, 2026
- EUDAMED d2645f62-71ba-4f85-bbe2-6a57e0b8e041 61 fields · synced Jul 12, 2026
- EUDAMED 02cf8f21-8218-49ed-bf18-016d13f7dc28 61 fields · synced Jul 15, 2026
- EUDAMED adff8fcc-b62b-4373-9252-5f8546e02286 61 fields · synced Jul 17, 2026
- EUDAMED b7085569-0fd9-47f1-a365-85d877b11ad7 61 fields · synced Jul 20, 2026
- EUDAMED 8f56248c-3f6b-41b4-82c1-b8849f5bb56f 61 fields · synced Jul 23, 2026
- EUDAMED e1ff15f3-50b7-48da-ae0a-e058a2282555 61 fields · synced Jul 24, 2026
- EUDAMED 4bd370c8-b16d-4a41-be72-61f67f2cd410 61 fields · synced Aug 2, 2026
- EUDAMED ec12732c-6e4a-4dc2-b08c-7af3d037a4f9 61 fields · synced Aug 3, 2026
- FDA 510(k) K203105 1 fields · synced May 18, 2026