Navigation Instruments 1001-N90118-M

GUDID 10888857379350

MI Awl-Tap, Size Ø 5.5mm DENALI MI

K2M, INC.

General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit

Primary Device ID	10888857379350
NIH Device Record Key	b3c40a6c-9710-462a-bdcb-b0ba8c655c43
Commercial Distribution Status	In Commercial Distribution
Brand Name	Navigation Instruments
Version Model Number	1001-N90118-M
Catalog Number	1001-N90118-M
Company DUNS	146060863
Company Name	K2M, INC.
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	false
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(703)777-3155
Email	mzellers@k2m.com
Phone	+1(703)777-3155
Email	mzellers@k2m.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10888857379350 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K171321

FDA Product Code

OLO	Orthopedic stereotaxic instrument

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[10888857379350]

Moist Heat or Steam Sterilization

[10888857379350]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	4
Public Version Date	2019-11-21
Device Publish Date	2017-09-12

On-Brand Devices [Navigation Instruments]

10888857384330	Polyaxial Screw Inserter, XTower
10888857380257	Tap, Size Ø5.5 mm MESA 2 Cortical
10888857380240	Tap, Size Ø5.0 mm MESA 2 Cortical
10888857380233	Tap, Size Ø4.5 mm MESA 2 Cortical
10888857380226	Tap, Size Ø4.0 mm MESA 2 Cortical
10888857380219	Tap, Size Ø3.5 mm MESA 2 Cortical
10888857380165	MESA 2 Tap, Size Ø7.0 mm
10888857380110	MESA 2 Tap, Size Ø8.5 mm
10888857380103	MESA 2 Tap, Size Ø7.5 mm
10888857380097	MESA 2 Tap, Size Ø6.5 mm
10888857380080	MESA 2 Tap, Size Ø6.0 mm
10888857380073	MESA 2 Tap, Size Ø5.5 mm
10888857380066	MESA 2 Tap, Size Ø5.0 mm
10888857380059	MESA 2 Tap, Size Ø4.5 mm
10888857380042	MESA 2 Tap, Size Ø4.0 mm
10888857380035	MESA 2 Tap, Size Ø3.5 mm
10888857379961	Locking Screw Inserter, XT, Cannulated, EVEREST XT
10888857379947	Tapered Thread Tap, Cannulated, Size Ø8.5 mm EVEREST MI
10888857379930	Tapered Thread Tap, Cannulated, Size Ø7.5 mm EVERESTMI
10888857379923	Tapered Thread Tap, Cannulated, Size Ø6.5 mm EVEREST MI
10888857379916	Tapered Thread Tap, Cannulated, Size Ø5.5 mm EVEREST MI
10888857379909	Tapered Thread Tap, Cannulated, Size Ø4.5 mm EVEREST MI
10888857379893	Tapered Thread Tap, Cannulated, Size Ø4.0 mm EVEREST MI
10888857379886	Cannulated Screw Inserter, EVEREST MI
10888857379879	Tap, Size Ø7.5 mm MESA Small Stature
10888857379862	Tap, Size Ø6.5 mm MESA Small Stature
10888857379855	Tap, Size Ø5.5 mm MESA Small Stature
10888857379848	Tap, Size Ø5.0 mm MESA Small Stature
10888857379831	Tap, Size Ø4.5 mm MESA Small Stature
10888857379824	Tap, Size Ø4.0 mm MESA Small Stature
10888857379817	Tap, Size Ø3.5 mm MESA Small Stature
10888857379800	Tap, Size Ø3.0 mm MESA Small Stature
10888857379794	Screw Inserter, MESA Small Stature
10888857379718	Awl Tap, Size Ø8.5 mm EVEREST
10888857379701	Awl Tap, Size Ø7.5 mm EVEREST
10888857379695	Awl Tap, Size Ø6.5 mm EVEREST
10888857379688	Awl Tap, Size Ø5.5 mm EVEREST
10888857379671	Awl Tap, Size Ø4.5 mm EVEREST
10888857379664	Awl Tap, Size Ø3.5 mm EVEREST
10888857379657	Tapered Tap, Size 8.5 mm EVEREST
10888857379640	Tapered Tap, Size 7.5 mm EVEREST
10888857379633	Tapered Tap, Size 6.5 mm EVEREST
10888857379626	Tapered Tap, Size 5.5 mm EVEREST
10888857379619	Tapered Tap, Size 4.5 mm EVEREST
10888857379602	Tapered Tap, Size 3.5 mm EVEREST
10888857379596	Polyaxial Screw Inserter, EVEREST
10888857379589	Awl Tap, Size Ø7.5 mm EVEREST
10888857379572	Awl Tap, Size Ø6.5 mm EVEREST
10888857379565	Awl Tap, Size Ø5.5 mm EVEREST
10888857379558	Awl Tap, Size Ø4.5 mm EVEREST