Brainlab Compatible K2M Navigation Instruments 5101-N90155-B

GUDID 10888857411470

Cannulated Tap (Undersized), Size 9.5mm EVEREST MI

K2M, INC.

General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit
Primary Device ID10888857411470
NIH Device Record Key8a1d6f6b-7326-4519-87d5-fb439b7b7d8c
Commercial Distribution StatusIn Commercial Distribution
Brand NameBrainlab Compatible K2M Navigation Instruments
Version Model Number5101-N90155-B
Catalog Number5101-N90155-B
Company DUNS146060863
Company NameK2M, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
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(703)777-3155
Emailmzellers@k2m.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com

Device Dimensions

Outer Diameter9.5 Millimeter
Device Size Text, specify0
Outer Diameter9.5 Millimeter
Device Size Text, specify0
Outer Diameter9.5 Millimeter
Device Size Text, specify0
Outer Diameter9.5 Millimeter
Device Size Text, specify0
Outer Diameter9.5 Millimeter
Device Size Text, specify0
Outer Diameter9.5 Millimeter
Device Size Text, specify0
Outer Diameter9.5 Millimeter
Device Size Text, specify0
Outer Diameter9.5 Millimeter
Device Size Text, specify0
Outer Diameter9.5 Millimeter
Device Size Text, specify0
Outer Diameter9.5 Millimeter
Device Size Text, specify0
Outer Diameter9.5 Millimeter
Device Size Text, specify0
Outer Diameter9.5 Millimeter
Device Size Text, specify0
Outer Diameter9.5 Millimeter
Device Size Text, specify0
Outer Diameter9.5 Millimeter
Device Size Text, specify0
Outer Diameter9.5 Millimeter
Device Size Text, specify0
Outer Diameter9.5 Millimeter
Device Size Text, specify0
Outer Diameter9.5 Millimeter
Device Size Text, specify0
Outer Diameter9.5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS110888857411470 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OLOOrthopedic stereotaxic instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10888857411470]

Moist Heat or Steam Sterilization

[10888857411470]

Moist Heat or Steam Sterilization

[10888857411470]

Moist Heat or Steam Sterilization

[10888857411470]

Moist Heat or Steam Sterilization

[10888857411470]

Moist Heat or Steam Sterilization

[10888857411470]

Moist Heat or Steam Sterilization

[10888857411470]

Moist Heat or Steam Sterilization

[10888857411470]

Moist Heat or Steam Sterilization

[10888857411470]

Moist Heat or Steam Sterilization

[10888857411470]

Moist Heat or Steam Sterilization

[10888857411470]

Moist Heat or Steam Sterilization

[10888857411470]

Moist Heat or Steam Sterilization

[10888857411470]

Moist Heat or Steam Sterilization

[10888857411470]

Moist Heat or Steam Sterilization

[10888857411470]

Moist Heat or Steam Sterilization

[10888857411470]

Moist Heat or Steam Sterilization

[10888857411470]

Moist Heat or Steam Sterilization

[10888857411470]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-05-10
Device Publish Date2019-04-19

On-Brand Devices [Brainlab Compatible K2M Navigation Instruments]

10888857411586Tap, Size 8.5mm MESA 2
10888857411579Tap, Size 7.5mm MESA 2
10888857411562Tap, Size 6.5mm MESA 2
10888857411548Tap, Size 5.5mm MESA 2
10888857411524Tap, Size 4.5mm MESA 2
10888857405523Polyaxial Screw Inserter, MESA 2
10888857405196Cannulated Tap, Size 8.5 mm EVEREST MI
10888857405189Cannulated Tap, Size 7.5 mm EVEREST MI
10888857405172Cannulated Tap, Size 6.5 mm EVEREST MI
10888857405165Cannulated Tap, Size 5.5 mm EVEREST MI
10888857405158Cannulated Tap, Size 4.5 mm EVEREST MI
10888857405141Cannulated Tap, Size 4.0 mm EVEREST MI
10888857405080Tapered Tap, Size 8.5mm EVEREST
10888857405073Tapered Tap, Size 7.5mm EVEREST
10888857405066Tapered Tap, Size 6.5mm EVEREST
10888857405059Tapered Tap, Size 5.5mm EVEREST
10888857405042Tapered Tap, Size 4.5mm EVEREST
10888857405035Tapered Tap, Size 3.5mm EVEREST
10888857405004Cannulated Screw Inserter, EVEREST MI
10888857404991Polyaxial Screw Inserter, EVEREST
10888857249615Straight Thoracic Probe,
10888857421387Awl, Navigation
10888857421370Straight Thoracic Probe, Navigation
10888857421363Straight Lumbar Probe, Navigation
10888857411838Awl Tap, Size 8.5mm DENALI
10888857411821Awl Tap, Size 7.5 mm DENALI
10888857411814Awl Tap, Size 6.5 mm DENALI
10888857411807Awl Tap, Size 5.5 mm DENALI
10888857411791Awl Tap, Size 4.5 mm DENALI
10888857411630Tap, Size 7.0mm MESA 2
10888857411623Tap, Size 12.5mm MESA 2
10888857411616Tap, Size 11.5mm MESA 2
10888857411609Tap, Size 10.5mm MESA 2
10888857411593Tap, Size 9.5mm MESA 2
10888857411555Tap, Size 6.0mm MESA 2
10888857411531Tap, Size 5.0mm MESA 2
10888857411517Tap, Size 4.0mm MESA2
10888857411500Tap, Size 3.5mm MESA 2
10888857411494Cannulated Tap, Size 10.5 mm EVEREST MI
10888857411487Cannulated Tap, Size 9.5 mm EVEREST MI
10888857411470Cannulated Tap (Undersized), Size 9.5mm EVEREST MI
10888857411463Tapered Tap, Size 10.5mm EVEREST
10888857411456Tapered Tap, Size 9.5mm EVEREST
10888857405547Cannulated Screw Inserter, DENALI MI
10888857405516Polyaxial Screw Inserter, MESA
10888857405493Locking Screw Inserter, EVEREST XTOWER
10888857405486Locking Screw Inserter, EVEREST
10888857405479Polyaxial Screw Inserter, EVEREST Closed
10888857405028Polyaxial Screw Inserter, MESA 2
10888857405011Polyaxial Screw Inserter, YUKON
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