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VyLink™

FDA UDI

Class II (US FDA UDI)

by Vy Spine Llc

Identity

Trade Name
VyLink™ FDA UDI
Generic Name
Internal spinal fixation procedure kit, reusable FDA UDI
Device Name
Swivel Rod Connector Counter Torque FDA UDI
Model / Reference
04-ICC-002 FDA UDI
Description
Swivel Rod Connector Counter Torque FDA UDI

Identifiers

Primary DI / UDI-DI
00840283401435 FDA UDI
510(k) Number
K213750 FDA UDI
FDA Product Code
NKB FDA UDI
KWP FDA UDI
KWQ FDA UDI
GMDN Term
Internal spinal fixation procedure kit, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3070 FDA UDI
888.3050 FDA UDI
888.3060 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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: Internal spinal fixation procedure kit, reusable

VyLink™ by Vy Spine Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Internal spinal fixation procedure kit, reusable.

Cleared under the same submission

K213750 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 23a31ba9-3134-4e0f-ac8b-79508cccf9a9 35 fields · synced May 30, 2026