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Tx™

FDA UDI

Class II (US FDA UDI)

by Innovasis, Inc.

Identity

Trade Name
Tx™ FDA UDI
Generic Name
Spinal implant trial FDA UDI
Device Name
Ti 6Al 4V (ELI) FDA UDI
Model / Reference
LS-397-1605 FDA UDI
Description
Ti 6Al 4V (ELI) FDA UDI

Identifiers

Catalog Number
LS-397-1605 FDA UDI
Primary DI / UDI-DI
M711LS39716050 FDA UDI
510(k) Number
K180078 FDA UDI
FDA Product Code
MAX FDA UDI
GMDN Term
Spinal implant trial 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

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size
Angle — 5 degree FDA UDI
Length — 28 Millimeter FDA UDI
Height — 16 Millimeter FDA UDI
Width — 10 Millimeter FDA UDI

Category: Spinal implant trial

Tx™ by Innovasis, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Spinal implant trial.

Cleared under the same submission

K180078 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Innovasis, Inc.

Sources (1)

  • FDA UDI ac57a67f-77e3-488f-9b8d-e60487a0ebbf 37 fields · synced May 31, 2026