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Lucent L

FDA UDI

Class I (US FDA UDI)

by Spinal Elements, Inc.

Identity

Trade Name
LUCENT L FDA UDI
Generic Name
Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
Device Name
LATERAL RAMP DISTRACTOR, 26MM X 4MM FDA UDI
Model / Reference
11941-264 FDA UDI
Description
LATERAL RAMP DISTRACTOR, 26MM X 4MM FDA UDI

Identifiers

Primary DI / UDI-DI
00840606162807 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
Orthopaedic prosthesis implantation positioning instrument, reusable 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

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic prosthesis implantation positioning instrument, reusable

A comprehensive medical device directory entry for the LUCENT L orthopaedic prosthesis implantation positioning instrument. This hand-held surgical instrument is designed to aid in the navigation and placement of orthopaedic prostheses, either manually or as a computer-assisted surgery (CAS) device.

Similar devices

Also classified as Orthopaedic prosthesis implantation positioning instrument, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Spinal Elements, Inc.

Sources (1)

  • FDA UDI ba68b443-dfdb-40d1-b0a9-52cc57e09887 33 fields · synced Jul 11, 2026