GUDID 00889024319455

ZIMMER TRABECULAR METAL TECHNOLOGY INC.

Spinal implant trial
Primary Device ID00889024319455
NIH Device Record Key6c2e2ad3-6104-4372-8c07-59dd2697d48c
Commercial Distribution StatusIn Commercial Distribution
Version Model Number96-161-32131
Company DUNS793120965
Company NameZIMMER TRABECULAR METAL TECHNOLOGY INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmer.com

Device Dimensions

Height13 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100889024319455 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQPSPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00889024319455]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-02-07
Device Publish Date2016-05-25

Devices Manufactured by ZIMMER TRABECULAR METAL TECHNOLOGY INC.

00889024223790 - TM Ardis®2020-06-23
00889024316515 - Mergence™-S2020-06-23
00889024317239 - Mergence™-S2020-06-23
00889024317307 - Mergence™-S2020-06-23
00889024317383 - Mergence™-S2020-06-23
00889024317970 - Mergence™-S2020-06-23
00889024318045 - Mergence™-S2020-06-23
00889024318076 - Mergence™-S2020-06-23

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