NAPA Access System 8030-90200

GUDID 10888857551602

Fixation Pin 220 mm

K2M, INC.

Internal spinal fixation procedure kit, single-use Internal spinal fixation procedure kit, single-use Internal spinal fixation procedure kit, single-use Internal spinal fixation procedure kit, single-use Internal spinal fixation procedure kit, single-use Internal spinal fixation procedure kit, single-use Internal spinal fixation procedure kit, single-use Internal spinal fixation procedure kit, single-use Internal spinal fixation procedure kit, single-use Internal spinal fixation procedure kit, single-use Internal spinal fixation procedure kit, single-use Internal spinal fixation procedure kit, single-use Internal spinal fixation procedure kit, single-use Internal spinal fixation procedure kit, single-use Internal spinal fixation procedure kit, single-use Internal spinal fixation procedure kit, single-use Internal spinal fixation procedure kit, single-use
Primary Device ID10888857551602
NIH Device Record Key182ff6b5-a5d0-40b8-97fc-acb06efc00f4
Commercial Distribution StatusIn Commercial Distribution
Brand NameNAPA Access System
Version Model Number8030-90200
Catalog Number8030-90200
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

Device Identifiers

Device Issuing AgencyDevice ID
GS110888857551602 [Primary]

FDA Product Code

LXHOrthopedic manual surgical instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10888857551602]

Moist Heat or Steam Sterilization

[10888857551602]

Moist Heat or Steam Sterilization

[10888857551602]

Moist Heat or Steam Sterilization

[10888857551602]

Moist Heat or Steam Sterilization

[10888857551602]

Moist Heat or Steam Sterilization

[10888857551602]

Moist Heat or Steam Sterilization

[10888857551602]

Moist Heat or Steam Sterilization

[10888857551602]

Moist Heat or Steam Sterilization

[10888857551602]

Moist Heat or Steam Sterilization

[10888857551602]

Moist Heat or Steam Sterilization

[10888857551602]

Moist Heat or Steam Sterilization

[10888857551602]

Moist Heat or Steam Sterilization

[10888857551602]

Moist Heat or Steam Sterilization

[10888857551602]

Moist Heat or Steam Sterilization

[10888857551602]

Moist Heat or Steam Sterilization

[10888857551602]

Moist Heat or Steam Sterilization

[10888857551602]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-01-12
Device Publish Date2024-01-04

On-Brand Devices [NAPA Access System]

10888857562974Instrument Tub
10888857562967Instrument Tub
10888857562950Caddy
10888857562837Instrument Tray
10888857562820Instrument Tray
10888857562813Instrument Tray
10888857562806Instrument Tray
10888857562790Instrument Tray
10888857562783Instrument Tray
10888857556386Retractor Arm, Left ATP
10888857556379Retractor Arm, Right ATP
10888857556362Retractor Rack ATP
10888857555884Coupler
10888857555815Mini Arm, Double Clip
10888857555808Mini Arm, Threaded Adaptor
10888857555631Lipped Blade 24mm, 240mm
10888857555624Lipped Blade 24mm, 230mm
10888857555617Lipped Blade 24mm, 220mm
10888857555600Lipped Blade 24mm, 210mm
10888857555594Lipped Blade 24mm, 200mm
10888857555587Lipped Blade 24mm, 190mm
10888857555570Lipped Blade 24mm, 180mm
10888857555563Lipped Blade 24mm, 170mm
10888857555556Lipped Blade 24mm, 160mm
10888857555549Lipped Blade 24mm, 150mm
10888857555532Lipped Blade 24mm, 140mm
10888857555525Lipped Blade 24mm, 130mm
10888857555518Lipped Blade 24mm, 120mm
10888857555501Lipped Blade 24mm, 110mm
10888857555495Lipped Blade 24mm, 100mm
10888857555488Lipped Blade 24mm, 90mm
10888857555471Lipped Blade 24mm, 80mm
10888857555464Lipped Blade 19mm, 240mm
10888857555457Lipped Blade 19mm, 230mm
10888857555440Lipped Blade 19mm, 220mm
10888857555433Lipped Blade 19mm, 210mm
10888857555426Lipped Blade 19mm, 200mm
10888857555419Lipped Blade 19mm, 190mm
10888857555402Lipped Blade 19mm, 180mm
10888857555396Lipped Blade 19mm, 170mm
10888857555389Lipped Blade 19mm, 160mm
10888857555372Lipped Blade 19mm, 150mm
10888857555365Lipped Blade 19mm, 140mm
10888857555358Lipped Blade 19mm, 130mm
10888857555341Lipped Blade 19mm, 120mm
10888857555334Lipped Blade 19mm, 110mm
10888857555327Lipped Blade 19mm, 100mm
10888857555310Lipped Blade 19mm, 90mm
10888857555303Lipped Blade 19mm, 80mm
10888857555297Hohmann Blade 24mm, 240mm
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.