Cross-Fuse® II PEEK IBF System 38-1450-9-6L

GUDID 00191083030050

INTERBODY FUSION DEVICE

Pioneer Surgical Technology, Inc.

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Primary Device ID00191083030050
NIH Device Record Key55b05609-e360-45be-a027-43bc28f6cc38
Commercial Distribution StatusIn Commercial Distribution
Brand NameCross-Fuse® II PEEK IBF System
Version Model Number38-1450-9-6L
Catalog Number38-1450-9-6L
Company DUNS793384496
Company NamePioneer Surgical Technology, Inc.
Device Count1
DM Exempttrue
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com

Device Dimensions

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Device Identifiers

Device Issuing AgencyDevice ID
GS100191083030050 [Primary]
GS100846468007393 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral fusion device with bone graft, lumbar

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-03-10
Device Publish Date2022-03-02

On-Brand Devices [Cross-Fuse® II PEEK IBF System]

00191083033761Sterilization Case
00191083033754Sterilization Case
00191083033679TRIAL SPACER
00191083033662TRIAL SPACER
00191083033631TRIAL SPACER
00191083033624TRIAL SPACER
00191083033617TRIAL SPACER
00191083033600TRIAL SPACER
00191083033570TRIAL SPACER
00191083033525TRIAL SPACER
00191083033488TRIAL SPACER
00191083033440TRIAL SPACER
00191083033396TRIAL SPACER
00191083033358TAMP
00191083033341SLIDER
00191083033334SLIDER
00191083033327SLIDER
00191083033310SLIDER
00191083033303SLIDER
00191083033273Inserter
00191083033242INSERTER
00191083033228INSERTER
00191083033167L4/L5 TRIAL SPACER, RIGHT
00191083033150L4/L5 TRIAL SPACER, LEFT
00191083033143L4/L5 TRIAL SPACER, RIGHT
00191083033136L4/L5 TRIAL SPACER, LEFT
00191083033129L4/L5 TRIAL SPACER, RIGHT
00191083033112L4/L5 TRIAL SPACER, LEFT
00191083033105L4/L5 TRIAL SPACER, RIGHT
00191083033099L4/L5 TRIAL SPACER, LEFT
00191083033082L4/L5 TRIAL SPACER, RIGHT
00191083033075L4/L5 TRIAL SPACER, LEFT
00191083032788L4/L5 TRIAL SPACER
00191083032771L4/L5 TRIAL SPACER
00191083032764L4/L5 TRIAL SPACER
00191083032733L4/L5 TRIAL SPACER
00191083032696L4/L5 TRIAL SPACER
00191083032689L4/L5 TRIAL SPACER
00191083032672L4/L5 TRIAL SPACER
00191083032641L4/L5 TRIAL SPACER
00191083032597L4/L5 TRIAL SPACER
00191083032542ANGLED INSERTER
00191083043272INTERBODY FUSION DEVICE
00191083043265INTERBODY FUSION DEVICE
00191083042695INTERBODY FUSION DEVICE
00191083042688INTERBODY FUSION DEVICE
00191083042671INTERBODY FUSION DEVICE
00191083042664INTERBODY FUSION DEVICE
00191083042657INTERBODY FUSION DEVICE
00191083042640INTERBODY FUSION DEVICE

Trademark Results [Cross-Fuse]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CROSS-FUSE
CROSS-FUSE
77284786 3544634 Live/Registered
Pioneer Surgical Technology, Inc.
2007-09-20

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