Amendia

GUDID 00840916102357

SPINAL ELEMENTS

Bone-screw internal spinal fixation system
Primary Device ID00840916102357
NIH Device Record Key27fbdb47-e0e7-4710-9f22-d0b14d63543e
Commercial Distribution StatusIn Commercial Distribution
Brand NameAmendia
Version Model Number10-06-6535-2
Company DUNS004022104
Company NameSPINAL ELEMENTS
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100840916102357 [Primary]

FDA Product Code

NKBOrthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840916102357]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-12-03
Device Publish Date2014-09-24

On-Brand Devices [Amendia]

0084091610372910-01-4540-7
0084091610371210-01-4535-7
0084091610370510-01-4530-7
0084091610286910-01-6550-1
0084091610285210-01-6545-1
0084091610284510-01-6540-1
0084091610281410-01-5550-1
0084091610267810-01-7550-2
0084091610265410-01-7540-2
0084091610259310-01-6550-2
0084091610258610-01-6545-2
0084091610238810-06-6550-2
0084091610236410-06-6540-2
0084091610235710-06-6535-2
0084091610231910-06-5540-2
0084091610226510-03-7555-2
0084091610225810-03-7550-2
0084091610223410-03-7540-2
0084091610217310-03-6550-2
0084091610215910-03-6540-2
0084091610174910-01-6540-5
0084091610173210-01-6535-5
0084091610136710-07
0084091610118310707-090
0084091610114510707-070
0084091610110710707-050
0084091610108410707-040
0084091610099510706-120
0084091610093310706-090
0084091610092610706-085
0084091610086510706-055
0084091610085810706-050
0084091610073510705-150
0084091610008729-1-4550

Trademark Results [Amendia]

Mark Image

Registration | Serial
Company
Trademark
Application Date
AMENDIA
AMENDIA
87481120 5479077 Live/Registered
Amendia, Inc.
2017-06-08
AMENDIA
AMENDIA
85135485 4277932 Live/Registered
Amendia, Inc.
2010-09-22
AMENDIA
AMENDIA
77520457 not registered Dead/Abandoned
Amendia, Inc.
2008-07-11

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