Identity
- Trade Name
- L-Varlock FDA UDI
- Generic Name
- Metallic spinal fusion cage, non-sterile FDA UDI
- Device Name
- The L-Varlock is a lumbar cage, for intervertebral body fusion. FDA UDI
- Model / Reference
- Lumbar posterior cage W13 H9 FDA UDI
- Description
- The L-Varlock is a lumbar cage, for intervertebral body fusion. FDA UDI
Identifiers
- Catalog Number
- VAL-CA-13-09 FDA UDI
- Primary DI / UDI-DI
- 03700406328056 FDA UDI
- 510(k) Number
- K080537 FDA UDI
- FDA Product Code
- MAX FDA UDI
- GMDN Term
- Metallic spinal fusion cage, non-sterile 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
Yes
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
MR Unsafe FDA UDI
Category: Metallic spinal fusion cage, non-sterile
L-Varlock by Kisco International — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Metallic spinal fusion cage, non-sterile.
- Silverstone Titanium Interbody Fusion System — Altus Spine · Class II
- Silverstone Titanium Interbody Fusion System — Altus Spine · Class II
- TraXis® — ZIMMER SPINE, INC. · Class II
- PLIF Cage — Eisertech, LLC · Class II
- IVA Cage Ti — Dio Medical Co., Ltd. · Class II
- Copperhead — EMINENT SPINE LLC · Class II
- SPIRA™-C Open Matrix Cervical Interbody — CAMBER SPINE TECHNOLOGIES · Class II
- IVA Cage Ti — Dio Medical Co., Ltd. · Class II
Cleared under the same submission
K080537 also covers:
- L-Varlock — KISCO INTERNATIONAL
- L-Varlock — KISCO INTERNATIONAL
- L-Varlock — KISCO INTERNATIONAL
- L-Varlock — KISCO INTERNATIONAL
- L-Varlock — KISCO INTERNATIONAL
- L-Varlock — KISCO INTERNATIONAL
- L-Varlock — KISCO INTERNATIONAL
- L-Varlock — SPINESOURCE INC
- L-Varlock — SPINESOURCE INC
- L-Varlock — SPINESOURCE INC
- L-Varlock — SPINESOURCE INC
- L-Varlock — SPINESOURCE 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Kisco International
Sources (1)
- FDA UDI c65f313e-f8de-4ca7-af77-8d69ab19b2c7 35 fields · synced Jun 6, 2026