HammerFuze

GUDID 00841731106865

HammerFUZE Implant 2.5x20 Angled_Ti Gold

VILEX IN TENNESSEE, INC.

Orthopaedic bone screw, non-bioabsorbable, non-sterile
Primary Device ID00841731106865
NIH Device Record Key97419a7c-c8c3-4990-b7e0-651313e131a4
Commercial Distribution StatusIn Commercial Distribution
Brand NameHammerFuze
Version Model NumberTH25-20T-1110
Company DUNS152008371
Company NameVILEX IN TENNESSEE, 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 Usetrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100841731106865 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00841731106865]

Moist Heat or Steam Sterilization


[00841731106865]

Moist Heat or Steam Sterilization


[00841731106865]

Moist Heat or Steam Sterilization


[00841731106865]

Moist Heat or Steam Sterilization


[00841731106865]

Moist Heat or Steam Sterilization


[00841731106865]

Moist Heat or Steam Sterilization


[00841731106865]

Moist Heat or Steam Sterilization


[00841731106865]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-08-03

On-Brand Devices [HammerFuze]

00841731106889HammerFUZE Implant 3.0x25 Angled_Ti Magenta
00841731106872HammerFUZE Implant 3.0x25 Str._Ti Magenta
00841731106865HammerFUZE Implant 2.5x20 Angled_Ti Gold
00841731106858HammerFUZE Implant 2.5x20 Str._Ti Gold
00841731106841HammerFUZE Implant 2.2x18 Angled_Ti L.Blue
00841731106834HammerFUZE Implant 2.2x18 Str._Ti L.Blue

Trademark Results [HammerFuze]

Mark Image

Registration | Serial
Company
Trademark
Application Date
HAMMERFUZE
HAMMERFUZE
86445627 5129525 Live/Registered
Vilex in Tennessee, Inc.
2014-11-05

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