Identity
- Trade Name
- Inion S-2 instrument FDA UDI
- Generic Name
- Surgical implant/trial-implant/sizer holder, reusable FDA UDI
- Device Name
- Plate holder FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- Plate holder FDA UDI
Identifiers
- Catalog Number
- C60 FDA UDI
- Primary DI / UDI-DI
- M224C6010 FDA UDI
- 510(k) Number
- K151360 FDA UDI
- FDA Product Code
- OJB FDA UDI
- GMDN Term
- Surgical implant/trial-implant/sizer holder, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3060 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Surgical implant/trial-implant/sizer holder, reusable
Inion S-2 instrument by Inion , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Surgical implant/trial-implant/sizer holder, reusable.
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Cleared under the same submission
K151360 also covers:
- Inion S-2 Instrument — Inion , Ltd.
- Inion S-2 instrument — Inion , Ltd.
- Inion S-2 instrument — Inion , Ltd.
- Inion S-2 instrument — Inion , Ltd.
- Inion S-2 instrument — Inion , Ltd.
- Inion S-2 instrument — Inion , Ltd.
- Inion S-2 instrument — Inion , Ltd.
- Inion S-2 instrument — Inion , Ltd.
- Inion S-2 instrument — Inion , Ltd.
- Inion S-2 instrument — Inion , Ltd.
- Inion S-2 instrument — Inion , Ltd.
- Inion S-2 instrument — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Inion , Ltd.
Sources (1)
- FDA UDI cf3c0afb-1928-4ec0-bd37-0c35beb96998 35 fields · synced May 30, 2026