FixxSure

GUDID M711201160

FixxSure Cross Link Hex Driver, SST, Radel

Innovasis, Inc.

Orthopaedic implant driver
Primary Device IDM711201160
NIH Device Record Key71c831be-7103-49b6-9faa-766ec7dafcd5
Commercial Distribution StatusIn Commercial Distribution
Brand NameFixxSure
Version Model Number20116
Company DUNS156567492
Company NameInnovasis, 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 Batchfalse
Serial Numbertrue
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

Phone801-261-2236
Emailinfo@innovasis.com
Phone801-261-2236
Emailinfo@innovasis.com
Phone801-261-2236
Emailinfo@innovasis.com
Phone801-261-2236
Emailinfo@innovasis.com
Phone801-261-2236
Emailinfo@innovasis.com
Phone801-261-2236
Emailinfo@innovasis.com
Phone801-261-2236
Emailinfo@innovasis.com
Phone801-261-2236
Emailinfo@innovasis.com
Phone801-261-2236
Emailinfo@innovasis.com
Phone801-261-2236
Emailinfo@innovasis.com
Phone801-261-2236
Emailinfo@innovasis.com
Phone801-261-2236
Emailinfo@innovasis.com
Phone801-261-2236
Emailinfo@innovasis.com
Phone801-261-2236
Emailinfo@innovasis.com
Phone801-261-2236
Emailinfo@innovasis.com
Phone801-261-2236
Emailinfo@innovasis.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM711201160 [Primary]

FDA Product Code

MNHOrthosis, Spondylolisthesis Spinal Fixation

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M711201160]

Moist Heat or Steam Sterilization


[M711201160]

Moist Heat or Steam Sterilization


[M711201160]

Moist Heat or Steam Sterilization


[M711201160]

Moist Heat or Steam Sterilization


[M711201160]

Moist Heat or Steam Sterilization


[M711201160]

Moist Heat or Steam Sterilization


[M711201160]

Moist Heat or Steam Sterilization


[M711201160]

Moist Heat or Steam Sterilization


[M711201160]

Moist Heat or Steam Sterilization


[M711201160]

Moist Heat or Steam Sterilization


[M711201160]

Moist Heat or Steam Sterilization


[M711201160]

Moist Heat or Steam Sterilization


[M711201160]

Moist Heat or Steam Sterilization


[M711201160]

Moist Heat or Steam Sterilization


[M711201160]

Moist Heat or Steam Sterilization


[M711201160]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-12-09
Device Publish Date2024-11-30

Devices Manufactured by Innovasis, Inc.

M711CCR0060 - C-Box®2025-06-09 6mm Cervical Cage Rasp, SST
M711CCR0070 - C-Box®2025-06-09 7mm Cervical Cage Rasp, SST
M711CCR0080 - C-Box®2025-06-09 8mm Cervical Cage Rasp, SST
M711CCR0090 - C-Box®2025-06-09 9mm Cervical Cage Rasp, SST
M711CCR0100 - C-Box®2025-06-09 10mm Cervical Cage Rasp, SST
M711CCR0110 - C-Box®2025-06-09 11mm Cervical Cage Rasp, SST
M711CCR0120 - C-Box®2025-06-09 12mm Cervical Cage Rasp, SST
M711CCS0060 - C-Box®2025-06-09 6mm Cervical Cage Sizer, SST

Trademark Results [FixxSure]

Mark Image

Registration | Serial
Company
Trademark
Application Date
FIXXSURE
FIXXSURE
77858763 3923949 Live/Registered
INNOVASIS, INC.
2009-10-27

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