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Inion FreedomPin instrumentation
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref INS-9257Ref INS-9236Ref INS-9284 Ref INS-9233Ref INS-9235Model INS-9235 Ref INS-9284
by Inion Oy
Identity
- Trade Name
- Inion FreedomPin instrumentation EUDAMEDInion FreedomPin™ Instruments EUDAMEDInion FreedomPin Instruments FDA UDI
- Generic Name
- Laparoscopic access cannula, reusable FDA UDISurgical drill guide, reusable FDA UDIFluted surgical drill bit, reusable FDA UDIBone awl, reusable FDA UDI
- Device Name
- Inion FreedomPin instrumentation EUDAMEDInion Instruments EUDAMEDInion FreedomPin Instruments EUDAMEDArthroscopic piston 1.5 mm FDA UDIK-wire 2.0 mm FDA UDIDrill bit 2.7 mm FDA UDIArthroscopic piston 2.0 mm FDA UDIArthroscopic tip 1.5 mm FDA UDI
- Model / Reference
- INS-9257 EUDAMEDINS-9236 EUDAMEDINS-9284 EUDAMEDINS-9233 EUDAMEDINS-9235 EUDAMED1 FDA UDI
- Description
- Arthroscopic piston 1.5 mm FDA UDIK-wire 2.0 mm FDA UDIDrill bit 2.7 mm FDA UDIArthroscopic piston 2.0 mm FDA UDIArthroscopic tip 1.5 mm FDA UDI
Identifiers
- Catalog Number
- INS-9235 FDA UDIINS-9257 FDA UDIINS-9284 FDA UDIINS-9236 FDA UDIINS-9233 FDA UDI
- Primary DI / UDI-DI
- 06438408004445 EUDAMEDFDA UDI06438408004483 EUDAMEDFDA UDI06438408004513 EUDAMEDFDA UDI06438408004421 EUDAMEDFDA UDI06438408004438 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06438408004445 EUDAMED6438408INION-IR-INSTRUM9T EUDAMEDB-06438408004513 EUDAMEDB-06438408004421 EUDAMEDB-06438408004438 EUDAMED6438408INION-IIA-INSTRUUR EUDAMEDB-06438408004483 EUDAMED
- Secondary DI
- M224INS92369 EUDAMEDM224INS92359 EUDAMEDM224INS92579 EUDAMEDM224INS92339 EUDAMEDM224INS92849 EUDAMED
- Direct Marketing DI
- 06438408004483 EUDAMED06438408004438 EUDAMED06438408004421 EUDAMED06438408004513 EUDAMED
- FDA Product Code
- NBH FDA UDILXH FDA UDIHTW FDA UDI
- EMDN Code
- L091001 INSTRUMENTS FOR INSERTION AND EXTRACTION OF MATERIALS FOR OSTEOSYNTHESIS, REUSABLE EUDAMED
- GMDN Term
- Laparoscopic access cannula, reusable FDA UDISurgical drill guide, reusable FDA UDIFluted surgical drill bit, reusable FDA UDIBone awl, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I EUDAMEDFDA UDI
- Regulation Number
- 888.1100 FDA UDI888.4540 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 FreedomPin instrumentation by Inion Oy — Class IIa — 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-06438408004445 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K133932 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06438408004445 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Inion Oy
- EUDAMED SRN
- FI-MF-000000646
Sources (20)
- EUDAMED afcbca14-bbe6-4c22-a23f-fb8e5af5d836 61 fields · synced Aug 4, 2026
- EUDAMED 66ea8af6-1ab2-4d3c-9c88-162e1c1ef990 61 fields · synced May 16, 2026
- EUDAMED 3ac536b3-31e6-4579-b57c-540e29361086 61 fields · synced May 17, 2026
- EUDAMED a4ba05eb-7ed6-4cf9-9f09-f83d85816f63 61 fields · synced May 17, 2026
- EUDAMED c001ea57-4caa-4e95-b3ef-f3f1c5e2cc83 61 fields · synced May 18, 2026
- EUDAMED e28af78c-1c89-4c57-9ecb-1d1db563e124 61 fields · synced May 18, 2026
- EUDAMED 30535586-2ecc-4b45-ac5d-a206981b58ca 61 fields · synced May 18, 2026
- EUDAMED a9088450-46a4-4916-82c2-14c5dd9a4175 61 fields · synced May 19, 2026
- EUDAMED dac0567c-7f35-4d74-85f1-631e747e37db 61 fields · synced May 19, 2026
- EUDAMED 3a7dc8b0-fae3-43df-b909-38c3cb96fc8d 61 fields · synced May 19, 2026
- FDA UDI 8236f11a-a0e6-402f-98b0-ae5830eadd4c 34 fields · synced May 30, 2026
- FDA UDI 099be39f-7710-4df5-bcc5-9efec5c9c47d 34 fields · synced May 30, 2026
- FDA UDI 691e7dbe-fd85-4e67-acf9-f7b222f5a5ef 34 fields · synced May 30, 2026
- FDA UDI bee67756-fbb8-464e-9502-1455cf45f308 34 fields · synced May 30, 2026
- FDA UDI 0f1e22f3-145f-4d40-b125-e30594f911ab 34 fields · synced May 30, 2026
- EUDAMED 7be18bfd-ebf9-4f5f-9ef8-94401cd2cff4 61 fields · synced Jul 9, 2026
- EUDAMED ed63734e-5c1d-4f02-8538-e87cc3caa22f 61 fields · synced Jul 10, 2026
- EUDAMED e7102c18-91e8-4918-8d30-534d682ee47c 61 fields · synced Jul 28, 2026
- EUDAMED a9410e55-aec9-4180-a5ee-19c01d518329 61 fields · synced Aug 4, 2026
- FDA 510(k) K133932 1 fields · synced May 18, 2026