Identity
- Trade Name
- Whistler Modular Pedicle Screw System FDA UDI
- Generic Name
- Orthopaedic implant driver FDA UDI
- Device Name
- POLYAXIAL SCREW INSERTER NAV CONNECTION FDA UDI
- Model / Reference
- WI-034-1 FDA UDI
- Description
- POLYAXIAL SCREW INSERTER NAV CONNECTION FDA UDI
Identifiers
- Catalog Number
- WI-034-1 FDA UDI
- Primary DI / UDI-DI
- 00195860008751 FDA UDI
- 510(k) Number
- K182478 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Orthopaedic implant driver FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 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 driver
Whistler Modular Pedicle Screw System by Evolution Spine, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K182478 also covers:
- Whistler Modular Pedicle Screw System — EVOLUTION SPINE, LLC
- Whistler Modular Pedicle Screw System — EVOLUTION SPINE, LLC
- Whistler Modular Pedicle Screw System — EVOLUTION SPINE, LLC
- Whistler Modular Pedicle Screw System — EVOLUTION SPINE, LLC
- Whistler Modular Pedicle Screw System — EVOLUTION SPINE, LLC
- Whistler Modular Pedicle Screw System — EVOLUTION SPINE, LLC
- Whistler Modular Pedicle Screw System — EVOLUTION SPINE, LLC
- Whistler Modular Pedicle Screw System — EVOLUTION SPINE, LLC
- Whistler Modular Pedicle Screw System — EVOLUTION SPINE, LLC
- Whistler Modular Pedicle Screw System — EVOLUTION SPINE, LLC
- Whistler Modular Pedicle Screw System — EVOLUTION SPINE, LLC
- Whistler Modular Pedicle Screw System — EVOLUTION SPINE, LLC
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Evolution Spine, Llc
Sources (1)
- FDA UDI 3eafdde9-92cb-4453-9c5e-ffdddbddac29 36 fields · synced Jun 1, 2026