Identity
- Trade Name
- Inion FreedomScrew™ FDA UDI
- Generic Name
- Bioabsorbable orthopaedic bone screw FDA UDI
- Device Name
- Screw 4.5 x 90 mm, cannul. FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- Screw 4.5 x 90 mm, cannul. FDA UDI
Identifiers
- Catalog Number
- OSC-4590 FDA UDI
- Primary DI / UDI-DI
- M224OSC45909 FDA UDI
- 510(k) Number
- K123672 FDA UDI
- FDA Product Code
- HWC FDA UDI
- GMDN Term
- Bioabsorbable orthopaedic bone screw 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: Bioabsorbable orthopaedic bone screw
Inion FreedomScrew™ by Inion , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bioabsorbable orthopaedic bone screw.
- MILAGRO — DePuy Mitek, Inc. · Class II
- ActivaScrew™ — Bioretec Oy · Class II
- MILAGRO — Medos International Sàrl · Class II
- Arthrex® — Arthrex, Inc. · Class II
- MILAGRO — Medos International Sàrl · Class II
- REUNITE SCREW SYSTEM — Biomet Orthopedics, Inc. · Class II
- Gentle Threads — Biomet Orthopedics, Inc. · Class II
- ActivaScrew™ — Bioretec Oy · Class II
Cleared under the same submission
K123672 also covers:
- Inion FreedomScrew™ — Inion , Ltd.
- Inion FreedomScrew™ — Inion , Ltd.
- Inion FreedomScrew™ — Inion , Ltd.
- Inion FreedomScrew™ — Inion , Ltd.
- Inion FreedomScrew™ — Inion , Ltd.
- Inion FreedomScrew™ — Inion , Ltd.
- Inion FreedomScrew™ — Inion , Ltd.
- Inion FreedomScrew™ — Inion , Ltd.
- Inion FreedomScrew™ — Inion , Ltd.
- Inion FreedomScrew™ — Inion , Ltd.
- Inion FreedomScrew™ — Inion , Ltd.
- Inion FreedomScrew™ — 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 3a1feaec-c3c5-4151-a107-33dd27dfab4f 36 fields · synced Jun 6, 2026