LITe Plate System 49174124

GUDID 07613327068023

1 LEVEL 4-SCREW PLATE

Stryker Corporation

Spinal fixation plate, non-bioabsorbable

Primary Device ID	07613327068023
NIH Device Record Key	8c399376-07e0-42db-b468-eeafe0013601
Commercial Distribution Status	In Commercial Distribution
Brand Name	LITe Plate System
Version Model Number	49174124
Catalog Number	49174124
Company DUNS	149183167
Company Name	Stryker Corporation
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Dimensions

Length	24 Millimeter
Length	24 Millimeter
Length	24 Millimeter
Length	24 Millimeter
Length	24 Millimeter
Length	24 Millimeter
Length	24 Millimeter
Length	24 Millimeter
Length	24 Millimeter
Length	24 Millimeter
Length	24 Millimeter
Length	24 Millimeter
Length	24 Millimeter
Length	24 Millimeter
Length	24 Millimeter
Length	24 Millimeter
Length	24 Millimeter
Length	24 Millimeter
Length	24 Millimeter
Length	24 Millimeter
Length	24 Millimeter
Length	24 Millimeter
Length	24 Millimeter
Length	24 Millimeter
Length	24 Millimeter
Length	24 Millimeter
Length	24 Millimeter
Length	24 Millimeter
Length	24 Millimeter
Length	24 Millimeter
Length	24 Millimeter
Length	24 Millimeter
Length	24 Millimeter
Length	24 Millimeter
Length	24 Millimeter
Length	24 Millimeter
Length	24 Millimeter
Length	24 Millimeter
Length	24 Millimeter
Length	24 Millimeter
Length	24 Millimeter
Length	24 Millimeter
Length	24 Millimeter
Length	24 Millimeter
Length	24 Millimeter
Length	24 Millimeter
Length	24 Millimeter
Length	24 Millimeter
Length	24 Millimeter
Length	24 Millimeter
Length	24 Millimeter
Length	24 Millimeter
Length	24 Millimeter
Length	24 Millimeter
Length	24 Millimeter
Length	24 Millimeter
Length	24 Millimeter
Length	24 Millimeter
Length	24 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327068023 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K142699

FDA Product Code

KWQ	APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[07613327068023]

Moist Heat or Steam Sterilization

[07613327068023]

Moist Heat or Steam Sterilization

[07613327068023]

Moist Heat or Steam Sterilization

[07613327068023]

Moist Heat or Steam Sterilization

[07613327068023]

Moist Heat or Steam Sterilization

[07613327068023]

Moist Heat or Steam Sterilization

[07613327068023]

Moist Heat or Steam Sterilization

[07613327068023]

Moist Heat or Steam Sterilization

[07613327068023]

Moist Heat or Steam Sterilization

[07613327068023]

Moist Heat or Steam Sterilization

[07613327068023]

Moist Heat or Steam Sterilization

[07613327068023]

Moist Heat or Steam Sterilization

[07613327068023]

Moist Heat or Steam Sterilization

[07613327068023]

Moist Heat or Steam Sterilization

[07613327068023]

Moist Heat or Steam Sterilization

[07613327068023]

Moist Heat or Steam Sterilization

[07613327068023]

Moist Heat or Steam Sterilization

[07613327068023]

Moist Heat or Steam Sterilization

[07613327068023]

Moist Heat or Steam Sterilization

[07613327068023]

Moist Heat or Steam Sterilization

[07613327068023]

Moist Heat or Steam Sterilization

[07613327068023]

Moist Heat or Steam Sterilization

[07613327068023]

Moist Heat or Steam Sterilization

[07613327068023]

Moist Heat or Steam Sterilization

[07613327068023]

Moist Heat or Steam Sterilization

[07613327068023]

Moist Heat or Steam Sterilization

[07613327068023]

Moist Heat or Steam Sterilization

[07613327068023]

Moist Heat or Steam Sterilization

[07613327068023]

Moist Heat or Steam Sterilization

[07613327068023]

Moist Heat or Steam Sterilization

[07613327068023]

Moist Heat or Steam Sterilization

[07613327068023]

Moist Heat or Steam Sterilization

[07613327068023]

Moist Heat or Steam Sterilization

[07613327068023]

Moist Heat or Steam Sterilization

[07613327068023]

Moist Heat or Steam Sterilization

[07613327068023]

Moist Heat or Steam Sterilization

[07613327068023]

Moist Heat or Steam Sterilization

[07613327068023]

Moist Heat or Steam Sterilization

[07613327068023]

Moist Heat or Steam Sterilization

[07613327068023]

Moist Heat or Steam Sterilization

[07613327068023]

Moist Heat or Steam Sterilization

[07613327068023]

Moist Heat or Steam Sterilization

[07613327068023]

Moist Heat or Steam Sterilization

[07613327068023]

Moist Heat or Steam Sterilization

[07613327068023]

Moist Heat or Steam Sterilization

[07613327068023]

Moist Heat or Steam Sterilization

[07613327068023]

Moist Heat or Steam Sterilization

[07613327068023]

Moist Heat or Steam Sterilization

[07613327068023]

Moist Heat or Steam Sterilization

[07613327068023]

Moist Heat or Steam Sterilization

[07613327068023]

Moist Heat or Steam Sterilization

[07613327068023]

Moist Heat or Steam Sterilization

[07613327068023]

Moist Heat or Steam Sterilization

[07613327068023]

Moist Heat or Steam Sterilization

[07613327068023]

Moist Heat or Steam Sterilization

[07613327068023]

Moist Heat or Steam Sterilization

[07613327068023]

Moist Heat or Steam Sterilization

[07613327068023]

Moist Heat or Steam Sterilization

[07613327068023]

Moist Heat or Steam Sterilization

[07613327068023]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	2
Public Version Date	2018-03-29
Device Publish Date	2015-09-14

On-Brand Devices [LITe Plate System]

07613327068115	STANDARD SCREW
07613327068108	STANDARD SCREW
07613327068092	STANDARD SCREW
07613327068085	STANDARD SCREW
07613327068078	STANDARD SCREW
07613327068047	1 LEVEL 4-SCREW PLATE
07613327068023	1 LEVEL 4-SCREW PLATE
07613327068016	1 LEVEL 4-SCREW PLATE
07613327068009	1 LEVEL 4-SCREW PLATE
07613327067996	1 LEVEL 4-SCREW PLATE
07613327067989	1 LEVEL 4-SCREW PLATE
07613327067972	1 LEVEL 2-SCREW PLATE
07613327067965	1 LEVEL 2-SCREW PLATE
07613327067958	1 LEVEL 2-SCREW PLATE
07613327067941	1 LEVEL 2-SCREW PLATE
07613327067934	1 LEVEL 2-SCREW PLATE
07613327067927	1 LEVEL 2-SCREW PLATE
07613327066630	REVISION SCREW
07613327066623	REVISION SCREW
07613327066616	REVISION SCREW
07613327066609	REVISION SCREW
07613327066593	REVISION SCREW
07613327066586	REVISION SCREW
07613327066579	REVISION SCREW
07613327066562	REVISION SCREW
07613327066555	REVISION SCREW
07613327066548	REVISION SCREW
07613327066531	REVISION SCREW
07613327066524	REVISION SCREW
07613327066517	STANDARD SCREW
07613327066500	STANDARD SCREW
07613327066494	STANDARD SCREW
07613327066487	STANDARD SCREW
07613327066470	STANDARD SCREW
07613327066463	STANDARD SCREW
07613327066456	STANDARD SCREW
07613327066449	1 LEVEL 2-SCREW PLATE
07613327066432	1 LEVEL SACRAL PLATE
07613327066425	1 LEVEL SACRAL PLATE
07613327066418	BUTTRESS PLATE
07613327066401	1 LEVEL SACRAL PLATE
07613327066395	1 LEVEL SACRAL PLATE
07613327066388	1 LEVEL SACRAL PLATE
07613327066371	1 LEVEL SACRAL PLATE
07613327066364	1 LEVEL SACRAL PLATE
07613327066357	1 LEVEL SACRAL PLATE
07613327066340	1 LEVEL UNIVERSAL PLATE
07613327066333	1 LEVEL UNIVERSAL PLATE
07613327066326	1 LEVEL SACRAL PLATE
07613327066319	1 LEVEL UNIVERSAL PLATE

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