Identity
- Trade Name
- VariLift-LX FDA UDI
- Generic Name
- Orthopaedic implant/instrument assembling device FDA UDI
- Device Name
- End Cap Driver FDA UDI
- Model / Reference
- CIE2-A505 FDA UDI
- Description
- End Cap Driver FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00813210020641 FDA UDI
- 510(k) Number
- K151900 FDA UDI
- FDA Product Code
- MAX FDA UDI
- GMDN Term
- Orthopaedic implant/instrument assembling device FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3080 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
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 implant/instrument assembling device
VariLift-LX by Wenzel Spine — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthopaedic implant/instrument assembling device.
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Cleared under the same submission
K151900 also covers:
- VariLift-LX — Wenzel Spine
- VariLift-LX — Wenzel Spine
- VariLift-LX — Wenzel Spine
- VariLift-LX — Wenzel Spine
- VariLift-LX — Wenzel Spine
- VariLift-LX — Wenzel Spine
- VariLift-LX — Wenzel Spine
- VariLift-LX — Wenzel Spine
- VariLift-LX — Wenzel Spine
- VariLift-LX — Wenzel Spine
- VariLift-LX — Wenzel Spine
- VariLift-LX — Wenzel Spine
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
- Wenzel Spine
Sources (1)
- FDA UDI 265ccfa8-3677-47b6-bcad-fbb8382aedf9 35 fields · synced Jun 8, 2026