Identity
- Trade Name
- Reliance Spinal Screw System FDA UDI
- Generic Name
- Bone-screw internal spinal fixation system, non-sterile FDA UDI
- Device Name
- Reliance MIS Ti Rod, Crv 6.0x80 FDA UDI
- Model / Reference
- 6-01-MIS080 FDA UDI
- Description
- Reliance MIS Ti Rod, Crv 6.0x80 FDA UDI
Identifiers
- Catalog Number
- 6-01-MIS080 FDA UDI
- Primary DI / UDI-DI
- 00842566105047 FDA UDI
- 510(k) Number
- K152131 FDA UDI
- FDA Product Code
- MNH FDA UDIKWQ FDA UDIKWP FDA UDIMNI FDA UDI
- GMDN Term
- Bone-screw internal spinal fixation system, non-sterile FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3070 FDA UDI888.3060 FDA UDI888.3050 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: Bone-screw internal spinal fixation system, non-sterile
Reliance Spinal Screw System by Vy Spine Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bone-screw internal spinal fixation system, non-sterile.
- TIGER Spine System — CORELINK LLC · Class II
- The JASPER Spinal Fixation System — GBS Commonwealth Co., Ltd. · Class II
- SILVERTON SPINAL FIXATION SYSTEM — BIOMET SPINE LLC · Class II
- POLARIS™ 5.5 SPINAL SYSTEM — BIOMET SPINE LLC · Class II
- Vitality® — BIOMET SPINE LLC · Class II
- The JASPER Spinal Fixation System — GBS Commonwealth Co., Ltd. · Class II
- PASS LP — Medicrea International SA · Class II
- The JASPER Spinal Fixation System — GBS Commonwealth Co., Ltd. · Class II
Cleared under the same submission
K152131 also covers:
- Reliance Spinal Screw System — VY SPINE LLC
- Reliance Spinal Screw System — VY SPINE LLC
- Reliance Spinal Screw System — VY SPINE LLC
- Reliance Spinal Screw System — VY SPINE LLC
- Reliance Spinal Screw System — VY SPINE LLC
- Reliance Spinal Screw System — VY SPINE LLC
- Reliance Spinal Screw System — VY SPINE LLC
- Reliance Spinal Screw System — VY SPINE LLC
- Reliance Spinal Screw System — VY SPINE LLC
- Reliance Spinal Screw System — VY SPINE LLC
- Reliance Spinal Screw System — VY SPINE LLC
- Reliance Spinal Screw 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 44030a2f-8cd1-4e9a-8c34-ce63a062fd32 36 fields · synced Jun 8, 2026