Lucent Lateral

GUDID 00840606184960

ANTERIOR EXTENSION, 12MM

SPINAL ELEMENTS, INC.

Orthopaedic prosthesis implantation positioning instrument, reusable
Primary Device ID00840606184960
NIH Device Record Key59da3e85-27a9-472d-84fd-5bec07d5b286
Commercial Distribution StatusIn Commercial Distribution
Brand NameLucent Lateral
Version Model Number89003-012
Company DUNS610712213
Company NameSPINAL ELEMENTS, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100840606184960 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840606184960]

Moist Heat or Steam Sterilization


[00840606184960]

Moist Heat or Steam Sterilization


[00840606184960]

Moist Heat or Steam Sterilization


[00840606184960]

Moist Heat or Steam Sterilization


[00840606184960]

Moist Heat or Steam Sterilization


[00840606184960]

Moist Heat or Steam Sterilization


[00840606184960]

Moist Heat or Steam Sterilization


[00840606184960]

Moist Heat or Steam Sterilization


[00840606184960]

Moist Heat or Steam Sterilization


[00840606184960]

Moist Heat or Steam Sterilization


[00840606184960]

Moist Heat or Steam Sterilization


[00840606184960]

Moist Heat or Steam Sterilization


[00840606184960]

Moist Heat or Steam Sterilization


[00840606184960]

Moist Heat or Steam Sterilization


[00840606184960]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-05-02
Device Publish Date2025-04-24

On-Brand Devices [Lucent Lateral]

00840606184946Probe Lateral Light Cable
00840606184922Dimension Light Cable
008406061865371.5mm x 14.5" Titanium K-Wire Arrow Tip
00840606185066EXTENSION KNOB, 220MM
00840606185059EXTENSION KNOB, 200MM
00840606185042EXTENSION KNOB, 180MM
00840606185035EXTENSION KNOB, 160MM
00840606185028EXTENSION KNOB, 140MM
00840606185011EXTENSION KNOB, 120MM
00840606185004ANTERIOR EXTENSION, 20MM
00840606184991ANTERIOR EXTENSION, 18MM
00840606184984ANTERIOR EXTENSION, 16MM
00840606184977ANTERIOR EXTENSION, 14MM
00840606184960ANTERIOR EXTENSION, 12MM
00840606184953ANTERIOR EXTENSION, 10MM

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.