PYRENEES Cervical Plate System 5901-90002

GUDID 10888857113213

Drill Size Ø3.0x16 mm

K2M, INC.

Internal spinal fixation procedure kit, single-use
Primary Device ID10888857113213
NIH Device Record Key2ca00994-a6f3-41e6-b4bb-3b632fc93f5d
Commercial Distribution StatusIn Commercial Distribution
Brand NamePYRENEES Cervical Plate System
Version Model Number5901-90002
Catalog Number5901-90002
Company DUNS146060863
Company NameK2M, 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(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
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 Diameter3 Millimeter
Length16 Millimeter
Outer Diameter3 Millimeter
Length16 Millimeter
Outer Diameter3 Millimeter
Length16 Millimeter
Outer Diameter3 Millimeter
Length16 Millimeter
Outer Diameter3 Millimeter
Length16 Millimeter
Outer Diameter3 Millimeter
Length16 Millimeter
Outer Diameter3 Millimeter
Length16 Millimeter
Outer Diameter3 Millimeter
Length16 Millimeter
Outer Diameter3 Millimeter
Length16 Millimeter
Outer Diameter3 Millimeter
Length16 Millimeter
Outer Diameter3 Millimeter
Length16 Millimeter
Outer Diameter3 Millimeter
Length16 Millimeter
Outer Diameter3 Millimeter
Length16 Millimeter
Outer Diameter3 Millimeter
Length16 Millimeter
Outer Diameter3 Millimeter
Length16 Millimeter
Outer Diameter3 Millimeter
Length16 Millimeter
Outer Diameter3 Millimeter
Length16 Millimeter
Outer Diameter3 Millimeter
Length16 Millimeter
Outer Diameter3 Millimeter
Length16 Millimeter
Outer Diameter3 Millimeter
Length16 Millimeter
Outer Diameter3 Millimeter
Length16 Millimeter
Outer Diameter3 Millimeter
Length16 Millimeter
Outer Diameter3 Millimeter
Length16 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS110888857113213 [Primary]

FDA Product Code

LXHOrthopedic manual surgical instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10888857113213]

Moist Heat or Steam Sterilization

[10888857113213]

Moist Heat or Steam Sterilization

[10888857113213]

Moist Heat or Steam Sterilization

[10888857113213]

Moist Heat or Steam Sterilization

[10888857113213]

Moist Heat or Steam Sterilization

[10888857113213]

Moist Heat or Steam Sterilization

[10888857113213]

Moist Heat or Steam Sterilization

[10888857113213]

Moist Heat or Steam Sterilization

[10888857113213]

Moist Heat or Steam Sterilization

[10888857113213]

Moist Heat or Steam Sterilization

[10888857113213]

Moist Heat or Steam Sterilization

[10888857113213]

Moist Heat or Steam Sterilization

[10888857113213]

Moist Heat or Steam Sterilization

[10888857113213]

Moist Heat or Steam Sterilization

[10888857113213]

Moist Heat or Steam Sterilization

[10888857113213]

Moist Heat or Steam Sterilization

[10888857113213]

Moist Heat or Steam Sterilization

[10888857113213]

Moist Heat or Steam Sterilization

[10888857113213]

Moist Heat or Steam Sterilization

[10888857113213]

Moist Heat or Steam Sterilization

[10888857113213]

Moist Heat or Steam Sterilization

[10888857113213]

Moist Heat or Steam Sterilization

[10888857113213]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-06-16
Device Publish Date2022-06-08

On-Brand Devices [PYRENEES Cervical Plate System]

10888857171565Clip
10888857113312Tap with Stop Size 10 mm
10888857113268Anti-Torque Guide
10888857113237Tap Size 10 mm
10888857113220Awl Size 10 mm
10888857113213Drill Size Ø3.0x16 mm
10888857113206Drill Size Ø3.0x14 mm
10888857113190Drill Size Ø3.0x12 mm
10888857030558Clip Size 1 mm
10888857247314Retaining Driver Size 13
10888857030480Fast Awl Size 10 mm
10888857030350Capture Driver, Sleeve Size 10
10888857030299Torque Limiting Handle Size 20 in-lbs (2.3 N-m)
10888857030275Drill, No Trocar Size Ø2.3x14 mm
10888857030268Drill, No Trocar Size Ø2.3x12 mm
10888857030251Drill, No Trocar Size Ø2.3x10 mm
10888857030244Non-Tapered Torque Driver Size 10
10888857030220Non-Tapered Torque Driver
10888857030213Spring Loaded Awl Size 10 mm
10888857030190Screw Extractor
10888857030183Tapered Driver Size 10
10888857030176Freehand Tap Size Ø2.3x10 mm
10888857030169Tap Size Ø2.3x10 mm
10888857030152Awl Size 10 mm
10888857030145Temporary Pin Inserter
10888857030138Drill Size Ø2.3x16 mm
10888857030121Drill Size Ø2.3x14 mm
10888857030114Drill Size Ø2.3x12 mm
10888857030107Drill Size Ø2.3x10 mm
10888857030091Thread Former
10888857030039Drill Size Ø2.3x16 mm
10888857030022Drill Size Ø2.3x14 mm
10888857030015Drill Size Ø2.3x12 mm
10888857030008Drill Size Ø2.3x10 mm
10888857029989Torque Limiting Handle (1/4" Square Quick Connect)
10888857029972Plate Bender, Cervical Universal
10888857029941Reduction Screw Size 14 mm
10888857029934Reduction Screw Size 12 mm
10888857029910Caliper
10888857029859Freehand Tap Size Ø4.0x10 mm
10888857029842Temporary Fixation Pin
10888857029835Spring Loaded Awl Size 10 mm
10888857029828Tap Size Ø4.0x10 mm
108888570297812.3mm Stop Drill Size 10mm
10888857029682Awl Size 10 mm
108888570296752.3mm Stop Drill Size 16mm
108888570296682.3mm Stop Drill Size 14mm
108888570296512.3mm Stop Drill Size 12mm
10888857029637Screw Extractor
10888857260498Tap Size ø2.3mm x 16mm
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