Identity
- Trade Name
- Medyssey Poseidon OCT Spinal Fixation System FDA UDI
- Generic Name
- Spinal bone screw, non-bioabsorbable FDA UDI
- Device Name
- Poseidon Reduction Smooth Shank Poly-Axial Screw, 3.5X22mm, 3.5mm rod FDA UDI
- Model / Reference
- RPPS3522 FDA UDI
- Description
- Poseidon Reduction Smooth Shank Poly-Axial Screw, 3.5X22mm, 3.5mm rod FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800048403458 FDA UDI
- FDA Product Code
- KWP FDA UDINKG FDA UDI
- GMDN Term
- Spinal bone screw, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3050 FDA UDI888.3075 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
No
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
Medyssey Poseidon OCT Spinal Fixation System by Medyssey Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Medyssey Co., Ltd.
Sources (1)
- FDA UDI 1e14a86e-94c6-4a95-be68-9b4ce557503f 34 fields · synced May 31, 2026