Identity
- Trade Name
- Signex FDA UDI
- Generic Name
- Orthopaedic bone screw (non-sliding) FDA UDI
- Model / Reference
- S1C.45450 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809539697673 FDA UDI
- 510(k) Number
- K230546 FDA UDI
- FDA Product Code
- HRS FDA UDIHWC FDA UDI
- GMDN Term
- Orthopaedic bone screw (non-sliding) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 FDA UDI888.3040 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic bone screw (non-sliding)
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Cleared under the same submission
K230546 also covers:
- Signex — OSTEONIC CO., Ltd.
- Signex — OSTEONIC CO., Ltd.
- Signex — OSTEONIC CO., Ltd.
- Signex — OSTEONIC CO., Ltd.
- Signex — OSTEONIC CO., Ltd.
- Signex — OSTEONIC CO., Ltd.
- Signex — OSTEONIC CO., Ltd.
- Signex — OSTEONIC CO., Ltd.
- Signex — OSTEONIC CO., Ltd.
- Signex — OSTEONIC CO., Ltd.
- Signex — OSTEONIC CO., Ltd.
- Signex — OSTEONIC CO., 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
- OSTEONIC CO., Ltd.
Sources (1)
- FDA UDI 9f0ee785-fc68-45ec-919c-f6dd86321cc0 33 fields · synced Jul 14, 2026