Identity
- Trade Name
- Valencia Pedicle Screw System FDA UDI
- Generic Name
- Bone tap, reprocessed FDA UDI
- Device Name
- 7.5mm Pedicle Tap, Cannulated FDA UDI
- Model / Reference
- 909-1075 FDA UDI
- Description
- 7.5mm Pedicle Tap, Cannulated FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00843210134734 FDA UDI
- FDA Product Code
- KWQ FDA UDIKWP FDA UDINKB FDA UDIMNH FDA UDIMNI FDA UDI
- GMDN Term
- Bone tap, reprocessed FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3060 FDA UDI888.3050 FDA UDI888.3070 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
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
Category: Bone tap, reprocessed
Valencia Pedicle Screw System by Altus Spine — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bone tap, reprocessed.
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- OrthoCircle Spine Pedicle Screw System — OrthoCircle Spine · Class II
- Boundary — NVISION BIOMEDICAL TECHNOLOGIES, INC · Class II
- Altus Spine Pedicle Screw System — Altus Spine · Class II
- Altus Spine Pedicle Screw System — Altus Spine · Class II
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
- Altus Spine
Sources (1)
- FDA UDI e8a17eeb-5e12-45b2-a291-229fa1e68955 34 fields · synced Jun 6, 2026