Identity
- Trade Name
- Reliance Lumbar IBF System FDA UDI
- Generic Name
- Polymeric spinal interbody fusion cage FDA UDI
- Device Name
- IBF, PEEK, 9x27x14, 0 Deg FDA UDI
- Model / Reference
- 1-14-014 FDA UDI
- Description
- IBF, PEEK, 9x27x14, 0 Deg FDA UDI
Identifiers
- Catalog Number
- 1-14-014 FDA UDI
- Primary DI / UDI-DI
- 00842566101285 FDA UDI
- 510(k) Number
- K113540 FDA UDI
- FDA Product Code
- MAX FDA UDI
- GMDN Term
- Polymeric spinal interbody fusion cage 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
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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Unsafe FDA UDI
Category: Polymeric spinal interbody fusion cage
Reliance Lumbar IBF System by Vy Spine Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Polymeric spinal interbody fusion cage.
- L-Box® — Innovasis, Inc. · Class II
- CoRoent — Nuvasive, Inc. · Class II
- Novel Spinal Spacer System — ALPHATEC SPINE, INC. · Class II
- S-LIFT® — SPINEFRONTIER, INC. · Class II
- Peridot Intervertebral body fusion system — GBS Commonwealth Co., Ltd. · Class II
- TAURUS PEEK Cage System — Medyssey Co., Ltd. · Class II
- Cross-Fuse® II PEEK IBF System — Rti Surgical, Inc. · Class II
- Kyocera Medical Technologies, Inc. — Kyocera Medical Technologies, Inc. · Class II
Cleared under the same submission
K113540 also covers:
- Reliance Lumbar IBF System — VY SPINE LLC
- Reliance Lumbar IBF System — VY SPINE LLC
- Reliance Lumbar IBF System — VY SPINE LLC
- Reliance Lumbar IBF System — VY SPINE LLC
- Reliance Lumbar IBF System — VY SPINE LLC
- Reliance Lumbar IBF System — VY SPINE LLC
- Reliance Lumbar IBF System — VY SPINE LLC
- Reliance Lumbar IBF System — VY SPINE LLC
- Reliance Lumbar IBF System — VY SPINE LLC
- Reliance Lumbar IBF System — VY SPINE LLC
- Reliance Lumbar IBF System — VY SPINE LLC
- Reliance Lumbar IBF System — VY 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 II | Pending data |
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Manufacturer
- Manufacturer
- Vy Spine Llc
Sources (1)
- FDA UDI 77d7276f-1239-49fa-b360-01796a784ef4 36 fields · synced Jun 1, 2026