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Non-Modular 6° Lordotic Trial Assembly

FDA UDI

Class I (US FDA UDI)

by Captiva Spine

Identity

Trade Name
Non-Modular 6° Lordotic Trial Assembly FDA UDI
Generic Name
General internal orthopaedic fixation system implantation kit FDA UDI
Model / Reference
19399-6913 FDA UDI

Identifiers

Primary DI / UDI-DI
M739193996913 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
General internal orthopaedic fixation system implantation kit FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.4540 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

No

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

Yes

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

Category: General internal orthopaedic fixation system implantation kit

Non-Modular 6° Lordotic Trial Assembly by Captiva Spine — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General internal orthopaedic fixation system implantation kit.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Captiva Spine

Sources (1)

  • FDA UDI a8d0d6f0-4e46-4490-9f6c-5d78d1845506 33 fields · synced May 29, 2026