Fortilink-A IBF System 65-A-SHAFT-A

GUDID 00846468092788

Anterolateral Inserter Shaft

Pioneer Surgical Technology, Inc.

Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable
Primary Device ID00846468092788
NIH Device Record Keyf014593e-f41b-45d1-a8a8-ab47855c6f5f
Commercial Distribution StatusIn Commercial Distribution
Brand NameFortilink-A IBF System
Version Model Number65-A-SHAFT-A
Catalog Number65-A-SHAFT-A
Company DUNS793384496
Company NamePioneer Surgical Technology, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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

Customer Support Contacts

Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100846468092788 [Primary]

FDA Product Code

LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00846468092788]

Moist Heat or Steam Sterilization


[00846468092788]

Moist Heat or Steam Sterilization


[00846468092788]

Moist Heat or Steam Sterilization


[00846468092788]

Moist Heat or Steam Sterilization


[00846468092788]

Moist Heat or Steam Sterilization


[00846468092788]

Moist Heat or Steam Sterilization


[00846468092788]

Moist Heat or Steam Sterilization


[00846468092788]

Moist Heat or Steam Sterilization


[00846468092788]

Moist Heat or Steam Sterilization


[00846468092788]

Moist Heat or Steam Sterilization


[00846468092788]

Moist Heat or Steam Sterilization


[00846468092788]

Moist Heat or Steam Sterilization


[00846468092788]

Moist Heat or Steam Sterilization


[00846468092788]

Moist Heat or Steam Sterilization


[00846468092788]

Moist Heat or Steam Sterilization


[00846468092788]

Moist Heat or Steam Sterilization


[00846468092788]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-01-20
Device Publish Date2020-01-10

On-Brand Devices [Fortilink-A IBF System]

00846468098414V Shape Tamp
00846468094010Interbody Fusion Device
00846468094003Interbody Fusion Device
00846468093990Interbody Fusion Device
00846468093983Interbody Fusion Device
00846468093976Interbody Fusion Device
00846468093969Interbody Fusion Device
00846468093952Interbody Fusion Device
00846468093945Interbody Fusion Device
00846468093938Interbody Fusion Device
00846468093921Interbody Fusion Device
00846468093914Interbody Fusion Device
00846468093907Interbody Fusion Device
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