Identity
- Trade Name
- 2.5 mm Inion OTPS™ FDA UDI
- Generic Name
- Orthopaedic fixation plate, bioabsorbable FDA UDI
- Device Name
- 4 hole plate FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- 4 hole plate FDA UDI
Identifiers
- Catalog Number
- FRF-1023 FDA UDI
- Primary DI / UDI-DI
- M224FRF10239 FDA UDI
- 510(k) Number
- K023887 FDA UDI
- FDA Product Code
- HRS FDA UDI
- GMDN Term
- Orthopaedic fixation plate, bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 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
Category: Orthopaedic fixation plate, bioabsorbable
2.5 mm Inion OTPS™ by Inion , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthopaedic fixation plate, bioabsorbable.
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Cleared under the same submission
K023887 also covers:
- 2.0 mm Inion OTPS™ — Inion , Ltd.
- 2.0 mm Inion OTPS™ — Inion , Ltd.
- 2.0 mm Inion OTPS™ — Inion , Ltd.
- 2.0 mm Inion OTPS™ — Inion , Ltd.
- 2.0 mm Inion OTPS™ — Inion , Ltd.
- 2.0 mm Inion OTPS™ — Inion , Ltd.
- 2.0 mm Inion OTPS™ — Inion , Ltd.
- 2.0 mm Inion OTPS™ — Inion , Ltd.
- 2.5 mm Inion OTPS™ — Inion , Ltd.
- 2.5 mm Inion OTPS™ — Inion , Ltd.
- 2.5 mm Inion OTPS™ — Inion , Ltd.
- 2.5 mm Inion OTPS™ — 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 54c24a49-90fd-421f-8f33-a8c7edfe3d74 36 fields · synced May 30, 2026