Reliance Spinal Screw System

FDA UDI

Class II (US FDA UDI)

by Vy Spine Llc

Identity

Trade Name: Reliance Spinal Screw System FDA UDI
Generic Name: Bone-screw internal spinal fixation system, non-sterile FDA UDI
Device Name: 4.5x25mm Screw FDA UDI
Model / Reference: 6-45-025 FDA UDI
Description: 4.5x25mm Screw FDA UDI

Identifiers

Catalog Number: 6-45-025 FDA UDI
Primary DI / UDI-DI: 00842566105337 FDA UDI
510(k) Number: K152131 FDA UDI
FDA Product Code: MNH FDA UDI
KWQ FDA UDI
KWP FDA UDI
MNI 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 UDI
888.3060 FDA UDI
888.3050 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Bone-screw internal spinal fixation system, non-sterile

Reliance Spinal Screw System is a non-sterile, internal spinal fixation system used for orthopedic treatment of various spinal instabilities or deformities. This device consists of a combination of anchors (e.g., bolts, hooks), interconnection mechanisms, longitudinal members, and/or transverse connectors, providing immobilization and stabilization of spinal segments. The Reliance Spinal Screw System is designed to be used with non-sterile disposable devices associated with implantation and offers a range of benefits for patients requiring internal spinal fixation.

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Cleared under the same submission

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 482a8311-c7e0-42f2-a45f-180227a639f0 36 fields · synced Jun 21, 2026

Reliance Spinal Screw System

Identity

Identifiers

Classification

Clinical & Handling

Similar devices

Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

Manufacturer

Sources (1)