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
- 004 FDA UDI
- Description
- The L-Varlock is a lumbar cage, for intervertebral body fusion. FDA UDI
Identifiers
- Catalog Number
- VAL-CA-13-08 FDA UDI
- Primary DI / UDI-DI
- 00850011324004 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
Dimensions & Sizes
- Size
- Width — 13 Millimeter FDA UDIHeight — 8 Millimeter FDA UDI
Category: Metallic spinal fusion cage, non-sterile
L-Varlock by Spinesource Inc — 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 — KISCO INTERNATIONAL
- 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 |
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Manufacturer
- Manufacturer
- Spinesource Inc
Sources (1)
- FDA UDI cff691c9-261f-4432-8d0e-cb9ff7d917aa 37 fields · synced Jun 1, 2026