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VersaTie

FDA UDI

Class II (US FDA UDI)

by Nuvasive, Inc.

Identity

Trade Name
VersaTie FDA UDI
Generic Name
Internal spinal fixation system cable FDA UDI
Device Name
VersaTie Clamp, 5/6.0mm Rod FDA UDI
Model / Reference
8610260P2 FDA UDI
Description
VersaTie Clamp, 5/6.0mm Rod FDA UDI

Identifiers

Primary DI / UDI-DI
00887517984784 FDA UDI
510(k) Number
K161265 FDA UDI
K173117 FDA UDI
K190418 FDA UDI
FDA Product Code
OWI FDA UDI
GMDN Term
Internal spinal fixation system cable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3010 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Radiation Sterilization FDA UDI

Category: Internal spinal fixation system cable

VersaTie by Nuvasive, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Internal spinal fixation system cable.

Cleared under the same submission

K161265 also covers:

K173117 also covers:

K190418 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Nuvasive, Inc.

Sources (1)

  • FDA UDI b3f2e365-548e-4128-8bfa-6863a05c2751 35 fields · synced May 30, 2026