Identity
- Trade Name
- Inion FreedomPin™ FDA UDI
- Generic Name
- Orthopaedic bone pin, bioabsorbable FDA UDI
- Device Name
- Pin 1.5 x 70 mm FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- Pin 1.5 x 70 mm FDA UDI
Identifiers
- Catalog Number
- OPA-1570 FDA UDI
- Primary DI / UDI-DI
- M224OPA15709 FDA UDI
- 510(k) Number
- K133932 FDA UDI
- FDA Product Code
- HTY FDA UDI
- GMDN Term
- Orthopaedic bone pin, bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Safe FDA UDI
Category: Orthopaedic bone pin, bioabsorbable
Inion FreedomPin™ by Inion , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic bone pin, bioabsorbable.
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- Self-Reinforced Technology — Conmed Corporation · Class II
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- ActivaPin™ — Bioretec Oy · Class II
Cleared under the same submission
K133932 also covers:
- Inion FreedomPin™ — Inion , Ltd.
- Inion FreedomPin™ — Inion , Ltd.
- Inion FreedomPin™ — Inion , Ltd.
- Inion FreedomPin™ — Inion , Ltd.
- Inion FreedomPin™ — Inion , Ltd.
- Inion FreedomPin™ — Inion , Ltd.
- Inion FreedomPin™ — Inion , Ltd.
- Inion FreedomPin™ — Inion , Ltd.
- Inion FreedomPin™ — Inion , Ltd.
- Inion FreedomPin™ — Inion , Ltd.
- Inion FreedomPin™ — Inion , Ltd.
- Inion FreedomPin™ — Inion , Ltd.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Inion , Ltd.
Sources (1)
- FDA UDI 061a29df-7c97-4206-ac5c-a45ec055cf1f 36 fields · synced May 30, 2026