Inlet Bone Fixation System

GUDID G079INL1160080

K-WIRE, Single Trocar, Round End, 6'' DIAXXmm

Intelivation, LLC

Orthopaedic intraoperative positioning pin, single-use Orthopaedic intraoperative positioning pin, single-use Orthopaedic intraoperative positioning pin, single-use Orthopaedic intraoperative positioning pin, single-use Orthopaedic intraoperative positioning pin, single-use Orthopaedic intraoperative positioning pin, single-use Orthopaedic intraoperative positioning pin, single-use Orthopaedic intraoperative positioning pin, single-use Orthopaedic intraoperative positioning pin, single-use Orthopaedic intraoperative positioning pin, single-use Orthopaedic intraoperative positioning pin, single-use Orthopaedic intraoperative positioning pin, single-use Orthopaedic intraoperative positioning pin, single-use Orthopaedic intraoperative positioning pin, single-use Orthopaedic intraoperative positioning pin, single-use Orthopaedic intraoperative positioning pin, single-use Orthopaedic intraoperative positioning pin, single-use Orthopaedic intraoperative positioning pin, single-use
Primary Device IDG079INL1160080
NIH Device Record Key3e3b650d-d941-43bc-8eba-00d74dece9de
Commercial Distribution StatusIn Commercial Distribution
Brand NameInlet Bone Fixation System
Version Model NumberINL-116-008
Company DUNS037368183
Company NameIntelivation, LLC
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

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCG079INL1160080 [Primary]

FDA Product Code

FZXGuide, Surgical, Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[G079INL1160080]

Moist Heat or Steam Sterilization


[G079INL1160080]

Moist Heat or Steam Sterilization


[G079INL1160080]

Moist Heat or Steam Sterilization


[G079INL1160080]

Moist Heat or Steam Sterilization


[G079INL1160080]

Moist Heat or Steam Sterilization


[G079INL1160080]

Moist Heat or Steam Sterilization


[G079INL1160080]

Moist Heat or Steam Sterilization


[G079INL1160080]

Moist Heat or Steam Sterilization


[G079INL1160080]

Moist Heat or Steam Sterilization


[G079INL1160080]

Moist Heat or Steam Sterilization


[G079INL1160080]

Moist Heat or Steam Sterilization


[G079INL1160080]

Moist Heat or Steam Sterilization


[G079INL1160080]

Moist Heat or Steam Sterilization


[G079INL1160080]

Moist Heat or Steam Sterilization


[G079INL1160080]

Moist Heat or Steam Sterilization


[G079INL1160080]

Moist Heat or Steam Sterilization


[G079INL1160080]

Moist Heat or Steam Sterilization


[G079INL1160080]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-02-08
Device Publish Date2024-01-31

On-Brand Devices [Inlet Bone Fixation System]

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G079INL139NT0500Temporary Pin, Non-threaded
G079INL139NT0400Temporary Pin, Non-threaded
G079INL139NT0290Temporary Pin, Non-threaded
G079INL1390700Temporary Pin
G079INL1390500Temporary Pin
G079INL1390400Temporary Pin
G079INL1390290Temporary Pin
G079INL1160200K-WIRE, Single Trocar, Round End, 6'' DIAXXmm
G079INL1160160K-WIRE, Single Trocar, Round End, 6'' DIAXXmm
G079INL1160130K-WIRE, Single Trocar, Round End, 6'' DIAXXmm
G079INL1160110K-WIRE, Single Trocar, Round End, 6'' DIAXXmm
G079INL1160080K-WIRE, Single Trocar, Round End, 6'' DIAXXmm

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