Perfix™ Spinal System

GUDID 08800037564726

U&I CORPORATION

Bone-screw internal spinal fixation system, non-sterile

Primary Device ID	08800037564726
NIH Device Record Key	e431200e-c1f4-4d03-8f4a-5a2364742bc5
Commercial Distribution Status	In Commercial Distribution
Brand Name	Perfix™ Spinal System
Version Model Number	SNM7180
Company DUNS	688811082
Company Name	U&I CORPORATION
Device Count	1
DM Exempt	true
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	true
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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800037564726 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K091725

FDA Product Code

MNH	Orthosis, spondylolisthesis spinal fixation

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[08800037564726]

Moist Heat or Steam Sterilization

[08800037564726]

Moist Heat or Steam Sterilization

[08800037564726]

Moist Heat or Steam Sterilization

[08800037564726]

Moist Heat or Steam Sterilization

[08800037564726]

Moist Heat or Steam Sterilization

[08800037564726]

Moist Heat or Steam Sterilization

[08800037564726]

Moist Heat or Steam Sterilization

[08800037564726]

Moist Heat or Steam Sterilization

[08800037564726]

Moist Heat or Steam Sterilization

[08800037564726]

Moist Heat or Steam Sterilization

[08800037564726]

Moist Heat or Steam Sterilization

[08800037564726]

Moist Heat or Steam Sterilization

[08800037564726]

Moist Heat or Steam Sterilization

[08800037564726]

Moist Heat or Steam Sterilization

[08800037564726]

Moist Heat or Steam Sterilization

[08800037564726]

Moist Heat or Steam Sterilization

[08800037564726]

Moist Heat or Steam Sterilization

[08800037564726]

Moist Heat or Steam Sterilization

[08800037564726]

Moist Heat or Steam Sterilization

[08800037564726]

Moist Heat or Steam Sterilization

[08800037564726]

Moist Heat or Steam Sterilization

[08800037564726]

Moist Heat or Steam Sterilization

[08800037564726]

Moist Heat or Steam Sterilization

[08800037564726]

Moist Heat or Steam Sterilization

[08800037564726]

Moist Heat or Steam Sterilization

[08800037564726]

Moist Heat or Steam Sterilization

[08800037564726]

Moist Heat or Steam Sterilization

[08800037564726]

Moist Heat or Steam Sterilization

[08800037564726]

Moist Heat or Steam Sterilization

[08800037564726]

Moist Heat or Steam Sterilization

[08800037564726]

Moist Heat or Steam Sterilization

[08800037564726]

Moist Heat or Steam Sterilization

[08800037564726]

Moist Heat or Steam Sterilization

[08800037564726]

Moist Heat or Steam Sterilization

[08800037564726]

Moist Heat or Steam Sterilization

[08800037564726]

Moist Heat or Steam Sterilization

[08800037564726]

Moist Heat or Steam Sterilization

[08800037564726]

Moist Heat or Steam Sterilization

[08800037564726]

Moist Heat or Steam Sterilization

[08800037564726]

Moist Heat or Steam Sterilization

[08800037564726]

Moist Heat or Steam Sterilization

[08800037564726]

Moist Heat or Steam Sterilization

[08800037564726]

Moist Heat or Steam Sterilization

[08800037564726]

Moist Heat or Steam Sterilization

[08800037564726]

Moist Heat or Steam Sterilization

[08800037564726]

Moist Heat or Steam Sterilization

[08800037564726]

Moist Heat or Steam Sterilization

[08800037564726]

Moist Heat or Steam Sterilization

[08800037564726]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2023-02-14
Device Publish Date	2023-02-06

On-Brand Devices [Perfix™ Spinal System]

08800037502292	SNS0026
08800037502285	SNS0025
08800037502278	SNS0024
08800015928335	SNA9180
08800015959827	SN0007
08800015959810	SN0006
08800015953962	SNS001-B
08800015953955	SNS001-A
08800015953948	SNS001
08800015953931	SN0924
08800015953924	SN0923
08800015953917	SN0922
08800015953900	SN0921
08800015953894	SN0920
08800015953887	SN0915
08800015953870	SN0914
08800015953863	SN0913
08800015953856	SN0912
08800015953849	SN0911
08800015953832	SN0910
08800015953825	SN003-D
08800015953818	SN003-C
08800015953801	SN003-B
08800015953795	SN003-A
08800015953788	SN003
08800015953771	SN002-D
08800015953764	SN002-C
08800015953757	SN002-B
08800015953740	SN002-A
08800015953733	SN002
08800015953726	SN001-E
08800015953719	SN001-D
08800015953702	SN001-C
08800015953696	SN001-B
08800015953689	SN001-A
08800015953672	SN001
08800015953665	SE001-C
08800015953658	SE001-B
08800015953641	SE001-A
08800015953634	SE001
08800015953627	SNS1001
08800015953610	SNS0020
08800015953603	SNS0019
08800015953597	SNS0018
08800015953580	SNS0017
08800015953573	SNS0016
08800015953566	SNS0015
08800015953559	SNS0014
08800015953542	SNS0013
08800015953535	SNS0012

Trademark Results [Perfix]

Mark Image Registration \| Serial	Company Trademark Application Date
PERFIX 90374997 not registered Live/Pending	Perfix Inc. 2020-12-11
PERFIX 85691869 4349179 Live/Registered	Atica Nails Inc. 2012-07-31
PERFIX 80985733 0985733 Dead/Cancelled	Applied Bioscience 0000-00-00
PERFIX 79005104 not registered Dead/Abandoned	Partnership Twello B.V. 2003-11-03
PERFIX 77145921 3439246 Dead/Cancelled	PERESYS (PROPRIETARY) LIMITED 2007-04-02
PERFIX 75568540 2295911 Dead/Cancelled	Affiniti L.L.C. 1998-10-13
PERFIX 74351154 1896892 Live/Registered	C.R. BARD, INC. 1993-01-22
PERFIX 74012649 1620984 Dead/Cancelled	VARIAN ASSOCIATES, INC. 1989-12-20
PERFIX 72235990 0818539 Dead/Expired	THOMAS L. KALAHAR, DOING BUSINESS AS KALAHAR & COMPANY AND PERF HOOK MANUFACTURING COMPANY 1966-01-07

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