Identity
- Trade Name
- Signex FDA UDI
- Generic Name
- Orthopaedic fixation plate, non-bioabsorbable FDA UDI
- Model / Reference
- G3F.50170 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809539698816 FDA UDI
- 510(k) Number
- K243469 FDA UDI
- FDA Product Code
- HRS FDA UDIHWC FDA UDI
- GMDN Term
- Orthopaedic fixation plate, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 FDA UDI888.3040 FDA UDI
- Commercial Distribution
- Not 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
Signex by OSTEONIC CO., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K243469 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 6c45dcd7-d9b6-4842-9091-081d44983686 34 fields · synced May 30, 2026