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Reliance Cervical IBF-S System

FDA UDI

Class II (US FDA UDI)

by Vy Spine Llc

Identity

Trade Name
Reliance Cervical IBF-S System FDA UDI
Generic Name
Bone-screw internal spinal fixation system, non-sterile FDA UDI
Device Name
Cervical IBF-S, Screw, Drilling Variable, 4.0, 20mm FDA UDI
Model / Reference
2-S40-DV20 FDA UDI
Description
Cervical IBF-S, Screw, Drilling Variable, 4.0, 20mm FDA UDI

Identifiers

Catalog Number
2-S40-DV20 FDA UDI
Primary DI / UDI-DI
00842566102138 FDA UDI
510(k) Number
K131429 FDA UDI
FDA Product Code
ODP FDA UDI
OVE FDA UDI
GMDN Term
Bone-screw internal spinal fixation system, 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
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 Cervical IBF-S 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.

Cleared under the same submission

K131429 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Vy Spine Llc

Sources (1)

  • FDA UDI 72b76fad-e1f0-4d2c-8e12-9a8e2197d562 36 fields · synced Jun 1, 2026