Identity
- Trade Name
- PSS Pedicle Screw System FDA UDI
- Generic Name
- Surgical screwdriver, single-use FDA UDI
- Device Name
- PSS: Disposable Tip FDA UDI
- Model / Reference
- 900-1019 FDA UDI
- Description
- PSS: Disposable Tip FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00843210134314 FDA UDI
- FDA Product Code
- KWP FDA UDIKWQ FDA UDIMNI FDA UDIMNH FDA UDI
- GMDN Term
- Surgical screwdriver, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3050 FDA UDI888.3060 FDA UDI888.3070 FDA UDI
- Commercial Distribution
- Not 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
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
Yes
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
PSS Pedicle Screw System by Altus Spine — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Altus Spine
Sources (1)
- FDA UDI faec77af-f873-4a55-872b-fdbe541e0c00 35 fields · synced Jun 8, 2026