Identity
- Trade Name
- Wiltrom Spinal Fixation System FDA UDI
- Generic Name
- Bone-screw internal spinal fixation system connector FDA UDI
- Device Name
- The Wiltrom Spinal Fixation System is comprised of screws, rods, cross-link connector and associated surgical instruments that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. The Wiltrom Spinal Fixation System is designed to be used to stabilize the vertebrae through a posterior approach. The Wiltrom spinal implants are made of Ti-6Al-4V ELI material which complies with ISO 5832-3 and ASTM F136. Wiltrom Spinal Fixation System is provided nonsterile, and the implants are for single use only. FDA UDI
- Model / Reference
- 40050140 Cross-Link Assembly ø=3.0 L=40 FDA UDI
- Description
- The Wiltrom Spinal Fixation System is comprised of screws, rods, cross-link connector and associated surgical instruments that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. The Wiltrom Spinal Fixation System is designed to be used to stabilize the vertebrae through a posterior approach. The Wiltrom spinal implants are made of Ti-6Al-4V ELI material which complies with ISO 5832-3 and ASTM F136. Wiltrom Spinal Fixation System is provided nonsterile, and the implants are for single use only. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04719873027460 FDA UDI
- 510(k) Number
- K202894 FDA UDI
- FDA Product Code
- NKB FDA UDI
- GMDN Term
- Bone-screw internal spinal fixation system connector FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3070 FDA UDI
- Commercial Distribution
- 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
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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Bone-screw internal spinal fixation system connector
Wiltrom Spinal Fixation System by Wiltrom Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K202894 also covers:
- Wiltrom Spinal Fixation System — WILTROM INC.
- Wiltrom Spinal Fixation System — WILTROM INC.
- Wiltrom Spinal Fixation System — WILTROM INC.
- Wiltrom Spinal Fixation System — WILTROM INC.
- Wiltrom Spinal Fixation System — WILTROM INC.
- Wiltrom Spinal Fixation System — WILTROM INC.
- Wiltrom Spinal Fixation System — WILTROM INC.
- Wiltrom Spinal Fixation System — WILTROM INC.
- Wiltrom Spinal Fixation System — WILTROM INC.
- Wiltrom Spinal Fixation System — WILTROM INC.
- Wiltrom Spinal Fixation System — WILTROM INC.
- Wiltrom Spinal Fixation System — WILTROM INC.
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
- Wiltrom Inc.
Sources (1)
- FDA UDI 5f92e9ca-ebec-4788-9cbb-9edb90fafcde 36 fields · synced May 31, 2026