Cross-Fuse® PEEK IBF System 35-1845-9-6

GUDID 00846468035266

INTERBODY FUSION DEVICE

Pioneer Surgical Technology, Inc.

Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage
Primary Device ID00846468035266
NIH Device Record Key167455da-5cab-4214-9ec7-848cb7b835aa
Commercial Distribution StatusIn Commercial Distribution
Brand NameCross-Fuse® PEEK IBF System
Version Model Number35-1845-9-6
Catalog Number35-1845-9-6
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

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Device Identifiers

Device Issuing AgencyDevice ID
GS100191083029252 [Primary]
GS100846468035266 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ODPIntervertebral fusion device with bone graft, cervical

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® PEEK IBF System]

00191083033716INSERTER
00191083033709INSERTER, MODULAR CLEANING
00846468040970INSERTER
00191083032511INSERTER, MODULAR CLEANING
00191083032504INSERTER, MODULAR CLEANING
00191083032498TRIAL SPACER
00846468039349TRIAL SPACER
00191083032474TRIAL SPACER
00846468039325TRIAL SPACER
00191083032405TRIAL SPACER
00191083032344TRIAL SPACER
00846468038991TRIAL SPACER
00191083032276TRIAL SPACER
00191083033747TRIAL CADDY
00191083033686INSTRUMENT CASE
00191083032436TRIAL SPACER
00846468039240TRIAL SPACER
00191083032399TRIAL SPACER
00191083032351TRIAL SPACER
00191083032320TRIAL SPACER
00191083032283TRIAL SPACER
00846468035877INTERBODY FUSION DEVICE
00846468035860INTERBODY FUSION DEVICE
00191083029771INTERBODY FUSION DEVICE
00191083029757INTERBODY FUSION DEVICE
00846468035808INTERBODY FUSION DEVICE
00191083029719INTERBODY FUSION DEVICE
00191083029702INTERBODY FUSION DEVICE
00846468035754INTERBODY FUSION DEVICE
00846468035747INTERBODY FUSION DEVICE
00191083029634INTERBODY FUSION DEVICE
00191083029627INTERBODY FUSION DEVICE
00191083029603INTERBODY FUSION DEVICE
00191083029597INTERBODY FUSION DEVICE
00846468035686INTERBODY FUSION DEVICE
00191083029559INTERBODY FUSION DEVICE
00846468035648INTERBODY FUSION DEVICE
00191083029535INTERBODY FUSION DEVICE
00191083029528INTERBODY FUSION DEVICE
00191083029504INTERBODY FUSION DEVICE
00191083029498INTERBODY FUSION DEVICE
00191083029474INTERBODY FUSION DEVICE
00191083029467INTERBODY FUSION DEVICE
00191083029450INTERBODY FUSION DEVICE
00846468035532INTERBODY FUSION DEVICE
00191083029412INTERBODY FUSION DEVICE
00846468092634INTERBODY FUSION DEVICE
00191083029399INTERBODY FUSION DEVICE
00846468092627INTERBODY FUSION DEVICE
00846468035471INTERBODY 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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