MOUNTAINEER 188322334

GUDID 10705034158495

MOUNTAINEER OCT SPINAL SYSTEM MONOAXIAL EXTENDED TAB SCREW 3.5 x 3.5 x 34mm

Medos International Sàrl

Bone-screw internal spinal fixation system, non-sterile

Primary Device ID	10705034158495
NIH Device Record Key	c5111f48-604e-4959-98dc-c703837afc48
Commercial Distribution Status	In Commercial Distribution
Brand Name	MOUNTAINEER
Version Model Number	188322334
Catalog Number	188322334
Company DUNS	482661753
Company Name	Medos International Sàrl
Device Count	1
DM Exempt	false
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	false
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

Customer Support Contacts

Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	10705034158495 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K103100

FDA Product Code

KWP	APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[10705034158495]

Moist Heat or Steam Sterilization

[10705034158495]

Moist Heat or Steam Sterilization

[10705034158495]

Moist Heat or Steam Sterilization

[10705034158495]

Moist Heat or Steam Sterilization

[10705034158495]

Moist Heat or Steam Sterilization

[10705034158495]

Moist Heat or Steam Sterilization

[10705034158495]

Moist Heat or Steam Sterilization

[10705034158495]

Moist Heat or Steam Sterilization

[10705034158495]

Moist Heat or Steam Sterilization

[10705034158495]

Moist Heat or Steam Sterilization

[10705034158495]

Moist Heat or Steam Sterilization

[10705034158495]

Moist Heat or Steam Sterilization

[10705034158495]

Moist Heat or Steam Sterilization

[10705034158495]

Moist Heat or Steam Sterilization

[10705034158495]

Moist Heat or Steam Sterilization

[10705034158495]

Moist Heat or Steam Sterilization

[10705034158495]

Moist Heat or Steam Sterilization

[10705034158495]

Moist Heat or Steam Sterilization

[10705034158495]

Moist Heat or Steam Sterilization

[10705034158495]

Moist Heat or Steam Sterilization

[10705034158495]

Moist Heat or Steam Sterilization

[10705034158495]

Moist Heat or Steam Sterilization

[10705034158495]

Moist Heat or Steam Sterilization

[10705034158495]

Moist Heat or Steam Sterilization

[10705034158495]

Moist Heat or Steam Sterilization

[10705034158495]

Moist Heat or Steam Sterilization

[10705034158495]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	4
Public Version Date	2019-10-04
Device Publish Date	2015-09-24

On-Brand Devices [MOUNTAINEER]

10705034466392	MOUNTAINEER OCT SPINAL SYSTEM DUAL DIAMETER ROD 3.5 5.5mm x 900mm
10705034466385	MOUNTAINEER OCT SPINAL SYSTEM DUAL DIAMETER ROD 3.5 5.5mm x 900mm
10705034290713	MOUNTAINEER OCT SPINAL SYSTEM MINI POLYAXIAL BONE SCREW 3.5 x 4.0 x 24mm
10705034290706	MOUNTAINEER OCT SPINAL SYSTEM MINI POLYAXIAL BONE SCREW 3.5 x 4.0 x 22mm
10705034290690	MOUNTAINEER OCT SPINAL SYSTEM MINI POLYAXIAL BONE SCREW 3.5 x 4.0 x 20mm
10705034290683	MOUNTAINEER OCT SPINAL SYSTEM MINI POLYAXIAL BONE SCREW 3.5 x 3.5 x 24mm
10705034290676	MOUNTAINEER OCT SPINAL SYSTEM MINI POLYAXIAL BONE SCREW 3.5 x 3.5 x 22mm
10705034290638	MOUNTAINEER OCT SPINAL SYSTEM MINI POLYAXIAL BONE SCREW 3.5 x 4.35 x 50mm
10705034290621	MOUNTAINEER OCT SPINAL SYSTEM MINI POLYAXIAL BONE SCREW 3.5 x 4.35 x 45mm
10705034290614	MOUNTAINEER OCT SPINAL SYSTEM MINI POLYAXIAL BONE SCREW 3.5 x 4.35 x 40mm
10705034290607	MOUNTAINEER OCT SPINAL SYSTEM MINI POLYAXIAL BONE SCREW 3.5 x 4.35 x 35mm
10705034290591	MOUNTAINEER OCT SPINAL SYSTEM MINI POLYAXIAL BONE SCREW 3.5 x 4.35 x 30mm
10705034290584	MOUNTAINEER OCT SPINAL SYSTEM MINI POLYAXIAL BONE SCREW 3.5 x 4.35 x 25mm
10705034290577	MOUNTAINEER OCT SPINAL SYSTEM MINI POLYAXIAL BONE SCREW 3.5 x 4.35 x 20mm
10705034290560	MOUNTAINEER OCT SPINAL SYSTEM STRAIGHT ROD 3.5mm x 400mm
10705034290553	MOUNTAINEER OCT SPINAL SYSTEM STRAIGHT ROD 3.5mm x 340mm
10705034290546	MOUNTAINEER OCT SPINAL SYSTEM STRAIGHT ROD 3.5mm x 300mm
10705034290539	MOUNTAINEER OCT SPINAL SYSTEM STRAIGHT ROD 3.5mm x 200mm
10705034290522	MOUNTAINEER OCT SPINAL SYSTEM STRAIGHT ROD 3.5mm x 120mm
10705034290515	MOUNTAINEER OCT SPINAL SYSTEM STRAIGHT ROD 3.5mm x 100mm
10705034290508	MOUNTAINEER OCT SPINAL SYSTEM STRAIGHT ROD 3.5mm x 95mm
10705034290492	MOUNTAINEER OCT SPINAL SYSTEM STRAIGHT ROD 3.5mm x 90mm
10705034290485	MOUNTAINEER OCT SPINAL SYSTEM STRAIGHT ROD 3.5mm x 85mm
10705034290478	MOUNTAINEER OCT SPINAL SYSTEM STRAIGHT ROD 3.5mm x 80mm
10705034290461	MOUNTAINEER OCT SPINAL SYSTEM STRAIGHT ROD 3.5mm x 75mm
10705034290454	MOUNTAINEER OCT SPINAL SYSTEM STRAIGHT ROD 3.5mm x 70mm
10705034290447	MOUNTAINEER OCT SPINAL SYSTEM STRAIGHT ROD 3.5mm x 65mm
10705034290430	MOUNTAINEER OCT SPINAL SYSTEM STRAIGHT ROD 3.5mm x 60mm
10705034290423	MOUNTAINEER OCT SPINAL SYSTEM STRAIGHT ROD 3.5mm x 55mm
10705034290416	MOUNTAINEER OCT SPINAL SYSTEM STRAIGHT ROD 3.5mm x 50mm
10705034290409	MOUNTAINEER OCT SPINAL SYSTEM STRAIGHT ROD 3.5mm x 45mm
10705034290393	MOUNTAINEER OCT SPINAL SYSTEM STRAIGHT ROD 3.5mm x 40mm
10705034290386	MOUNTAINEER OCT SPINAL SYSTEM STRAIGHT ROD 3.5mm x 35mm
10705034290379	MOUNTAINEER OCT SPINAL SYSTEM STRAIGHT ROD 3.5mm x 30mm
10705034290362	MOUNTAINEER OCT SPINAL SYSTEM STRAIGHT ROD 3.5mm x 25mm
10705034290355	MOUNTAINEER OCT SPINAL SYSTEM DUAL DIAMETER ROD 3.5mm - 4.5mm x 600mm
10705034290348	MOUNTAINEER OCT SPINAL SYSTEM DUAL DIAMETER ROD 3.5mm - 6.35mm x 600mm
10705034290331	MOUNTAINEER OCT SPINAL SYSTEM DUAL DIAMETER ROD 3.5mm - 5.5mm x 600mm
10705034290324	MOUNTAINEER OCT SPINAL SYSTEM DUAL DIAMETER ROD 3.5mm - 4.75mm x 600mm
10705034290317	MOUNTAINEER OCT SPINAL SYSTEM DUAL DIAMETER ROD 3.5mm - 4.5mm x 420mm
10705034290300	MOUNTAINEER OCT SPINAL SYSTEM DUAL DIAMETER ROD 3.5mm - 6.35mm x 420mm
10705034290294	MOUNTAINEER OCT SPINAL SYSTEM DUAL DIAMETER ROD 3.5mm - 5.5mm x 420mm
10705034290287	MOUNTAINEER OCT SPINAL SYSTEM DUAL DIAMETER ROD 3.5mm - 4.75mm x 420mm
10705034159089	MOUNTAINEER OCT SPINAL SYSTEM LATERAL WASHER 2mm
10705034159072	MOUNTAINEER OCT SPINAL SYSTEM OCCIPITAL ADJUSTABLE ROD 3.5 x 120mm - 72mm
10705034159058	MOUNTAINEER OCT SPINAL SYSTEM OCCIPITAL ADJUSTABLE ROD 3.5 x 220mm - 72mm
10705034159034	MOUNTAINEER OCT SPINAL SYSTEM OC ROD CAP SCREW 3.5
10705034159027	MOUNTAINEER OCT SPINAL SYSTEM PRE-BENT SPINAL ROD 3.5 x 120mm - 85mm
10705034159010	MOUNTAINEER OCT SPINAL SYSTEM PRE-BENT SPINAL ROD 3.5 x 200mm - 85mm
10705034159003	MOUNTAINEER OCT SPINAL SYSTEM OCCIPITAL BONE SCREW 5.25 x 16mm

Trademark Results [MOUNTAINEER]

Mark Image Registration \| Serial	Company Trademark Application Date
MOUNTAINEER 90597572 not registered Live/Pending	B&S Beverages LLC 2021-03-23
MOUNTAINEER 87790500 5672808 Live/Registered	Mountaineer Partners Management, LLC 2018-02-08
MOUNTAINEER 87674664 not registered Dead/Abandoned	MOUNTAINEER CAPITAL MANAGEMENT LP 2017-11-07
MOUNTAINEER 87081272 5091270 Live/Registered	ALTITUDE CROP INNOVATIONS, LLC 2016-06-23
MOUNTAINEER 86660106 not registered Dead/Abandoned	Burgess Cellars Inc. 2015-06-11
MOUNTAINEER 86145161 4665931 Live/Registered	The Mountaineer 2013-12-16
MOUNTAINEER 85364300 4102092 Live/Registered	MODERN MUZZLELOADING, INC. 2011-07-06
MOUNTAINEER 80991965 0991965 Dead/Cancelled	Bulova Watch Company, Inc. 0000-00-00
MOUNTAINEER 78974542 3385618 Dead/Cancelled	Eagle Mountain Brokers Inc. 2006-09-14
MOUNTAINEER 78695954 3195221 Dead/Cancelled	Best Motor Company Leasing, Inc. 2005-08-18
MOUNTAINEER 78676358 not registered Dead/Abandoned	Great Neck Saw Manufacturers, 2005-07-22
MOUNTAINEER 78571092 not registered Dead/Abandoned	Arnold Engineering, Inc. 2005-02-18

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.