176012050

GUDID 10705034035987

SURGICAL TITANIUM MESH MESH, ROUND 12 x 50mm

DEPUY SPINE, LLC

Metallic spinal fusion cage, non-sterile

Primary Device ID	10705034035987
NIH Device Record Key	a7bdc7b2-69df-4fdc-98a2-c6a250ed43d1
Commercial Distribution Status	In Commercial Distribution
Version Model Number	176012050
Catalog Number	176012050
Company DUNS	107105876
Company Name	DEPUY SPINE, LLC
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	false
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

Customer Support Contacts

Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
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Phone	+1(800)255-2500
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Phone	+1(800)255-2500
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Phone	+1(800)255-2500
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Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	10705034035987 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K003043

FDA Product Code

MQP	SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[10705034035987]

Moist Heat or Steam Sterilization

[10705034035987]

Moist Heat or Steam Sterilization

[10705034035987]

Moist Heat or Steam Sterilization

[10705034035987]

Moist Heat or Steam Sterilization

[10705034035987]

Moist Heat or Steam Sterilization

[10705034035987]

Moist Heat or Steam Sterilization

[10705034035987]

Moist Heat or Steam Sterilization

[10705034035987]

Moist Heat or Steam Sterilization

[10705034035987]

Moist Heat or Steam Sterilization

[10705034035987]

Moist Heat or Steam Sterilization

[10705034035987]

Moist Heat or Steam Sterilization

[10705034035987]

Moist Heat or Steam Sterilization

[10705034035987]

Moist Heat or Steam Sterilization

[10705034035987]

Moist Heat or Steam Sterilization

[10705034035987]

Moist Heat or Steam Sterilization

[10705034035987]

Moist Heat or Steam Sterilization

[10705034035987]

Moist Heat or Steam Sterilization

[10705034035987]

Moist Heat or Steam Sterilization

[10705034035987]

Moist Heat or Steam Sterilization

[10705034035987]

Moist Heat or Steam Sterilization

[10705034035987]

Moist Heat or Steam Sterilization

[10705034035987]

Moist Heat or Steam Sterilization

[10705034035987]

Moist Heat or Steam Sterilization

[10705034035987]

Moist Heat or Steam Sterilization

[10705034035987]

Moist Heat or Steam Sterilization

[10705034035987]

Moist Heat or Steam Sterilization

[10705034035987]

Moist Heat or Steam Sterilization

[10705034035987]

Moist Heat or Steam Sterilization

[10705034035987]

Moist Heat or Steam Sterilization

[10705034035987]

Moist Heat or Steam Sterilization

[10705034035987]

Moist Heat or Steam Sterilization

[10705034035987]

Moist Heat or Steam Sterilization

[10705034035987]

Moist Heat or Steam Sterilization

[10705034035987]

Moist Heat or Steam Sterilization

[10705034035987]

Moist Heat or Steam Sterilization

[10705034035987]

Moist Heat or Steam Sterilization

[10705034035987]

Moist Heat or Steam Sterilization

[10705034035987]

Moist Heat or Steam Sterilization

[10705034035987]

Moist Heat or Steam Sterilization

[10705034035987]

Moist Heat or Steam Sterilization

[10705034035987]

Moist Heat or Steam Sterilization

[10705034035987]

Moist Heat or Steam Sterilization

[10705034035987]

Moist Heat or Steam Sterilization

[10705034035987]

Moist Heat or Steam Sterilization

[10705034035987]

Moist Heat or Steam Sterilization

[10705034035987]

Moist Heat or Steam Sterilization

[10705034035987]

Moist Heat or Steam Sterilization

[10705034035987]

Moist Heat or Steam Sterilization

[10705034035987]

Moist Heat or Steam Sterilization

[10705034035987]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	4
Public Version Date	2019-11-06
Device Publish Date	2015-09-24

Devices Manufactured by DEPUY SPINE, LLC

10705034187969 - I/F CAGE	2025-12-08 CERVICAL I/F CAGE FILLER BLOCK
10705034187976 - BENGAL	2025-12-08 BENGAL SYSTEM TAMP, STRAIGHT
10705034187983 - BENGAL	2025-12-08 BENGAL SYSTEM CANCELLOUS BONE TAMP
10705034188010 - BENGAL	2025-12-08 BENGAL SYSTEM INSERTION TIPS, STANDARD
10705034188034 - NA	2025-12-08 UNIVERSAL INSTRUMENTS FILLER BLOCK
10705034188058 - BENGAL	2025-12-08 BENGAL SYSTEM FILLER BLOCK
10705034188065 - BENGAL	2025-12-08 BENGAL SYSTEM BONE FILLER BLOCK, EXTRA LARGE
10705034188133 - BENGAL	2025-12-08 BENGAL SYSTEM RASP/TRIAL, STANDARD 9

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