PEEK Corpectomy

GUDID 00887517672452

PEEK Corpectomy Railed Endcap Module

Nuvasive, Inc.

Sterilization/disinfection container Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable
Primary Device ID00887517672452
NIH Device Record Keye53ae511-4193-4eeb-aa13-5a450400c2e3
Commercial Distribution StatusIn Commercial Distribution
Brand NamePEEK Corpectomy
Version Model NumberALPCRVPEEKRAILED
Company DUNS053950783
Company NameNuvasive, 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(858)909-1800
EmailRA_UDI@nuvasive.com
Phone+1(858)909-1800
EmailRA_UDI@nuvasive.com
Phone+1(858)909-1800
EmailRA_UDI@nuvasive.com
Phone+1(858)909-1800
EmailRA_UDI@nuvasive.com
Phone+1(858)909-1800
EmailRA_UDI@nuvasive.com
Phone+1(858)909-1800
EmailRA_UDI@nuvasive.com
Phone+1(858)909-1800
EmailRA_UDI@nuvasive.com
Phone+1(858)909-1800
EmailRA_UDI@nuvasive.com
Phone+1(858)909-1800
EmailRA_UDI@nuvasive.com
Phone+1(858)909-1800
EmailRA_UDI@nuvasive.com
Phone+1(858)909-1800
EmailRA_UDI@nuvasive.com
Phone+1(858)909-1800
EmailRA_UDI@nuvasive.com
Phone+1(858)909-1800
EmailRA_UDI@nuvasive.com
Phone+1(858)909-1800
EmailRA_UDI@nuvasive.com
Phone+1(858)909-1800
EmailRA_UDI@nuvasive.com
Phone+1(858)909-1800
EmailRA_UDI@nuvasive.com
Phone+1(858)909-1800
EmailRA_UDI@nuvasive.com
Phone+1(858)909-1800
EmailRA_UDI@nuvasive.com
Phone+1(858)909-1800
EmailRA_UDI@nuvasive.com
Phone+1(858)909-1800
EmailRA_UDI@nuvasive.com
Phone+1(858)909-1800
EmailRA_UDI@nuvasive.com
Phone+1(858)909-1800
EmailRA_UDI@nuvasive.com
Phone+1(858)909-1800
EmailRA_UDI@nuvasive.com
Phone+1(858)909-1800
EmailRA_UDI@nuvasive.com
Phone+1(858)909-1800
EmailRA_UDI@nuvasive.com
Phone+1(858)909-1800
EmailRA_UDI@nuvasive.com
Phone+1(858)909-1800
EmailRA_UDI@nuvasive.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100887517672452 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KCTSterilization wrap containers, trays, cassettes & other accessories

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00887517672452]

Moist Heat or Steam Sterilization


[00887517672452]

Moist Heat or Steam Sterilization


[00887517672452]

Moist Heat or Steam Sterilization


[00887517672452]

Moist Heat or Steam Sterilization


[00887517672452]

Moist Heat or Steam Sterilization


[00887517672452]

Moist Heat or Steam Sterilization


[00887517672452]

Moist Heat or Steam Sterilization


[00887517672452]

Moist Heat or Steam Sterilization


[00887517672452]

Moist Heat or Steam Sterilization


[00887517672452]

Moist Heat or Steam Sterilization


[00887517672452]

Moist Heat or Steam Sterilization


[00887517672452]

Moist Heat or Steam Sterilization


[00887517672452]

Moist Heat or Steam Sterilization


[00887517672452]

Moist Heat or Steam Sterilization


[00887517672452]

Moist Heat or Steam Sterilization


[00887517672452]

Moist Heat or Steam Sterilization


[00887517672452]

Moist Heat or Steam Sterilization


[00887517672452]

Moist Heat or Steam Sterilization


[00887517672452]

Moist Heat or Steam Sterilization


[00887517672452]

Moist Heat or Steam Sterilization


[00887517672452]

Moist Heat or Steam Sterilization


[00887517672452]

Moist Heat or Steam Sterilization


[00887517672452]

Moist Heat or Steam Sterilization


[00887517672452]

Moist Heat or Steam Sterilization


[00887517672452]

Moist Heat or Steam Sterilization


[00887517672452]

Moist Heat or Steam Sterilization


[00887517672452]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-09-10
Device Publish Date2016-09-23

On-Brand Devices [PEEK Corpectomy]

00887517624628PEEK Corpectomy Inserter
00887517672452PEEK Corpectomy Railed Endcap Module
00887517665294Alpha PEEK Corpectomy Instrument Tray
00887517665287Alpha PEEK Corpectomy Implant Tray
00887517659880PEEK Corpectomy Driver, Railed
00887517659873PEEK Corpectomy Distractor, Railed
00887517650757PEEK Corp Endcap, 19x16x7 Lord Ø14 Rail
00887517650740PEEK Corp Endcap, 17x15x7 Lord Ø14 Rail
00887517650733PEEK Corp Endcap, 22x19x7 Lord Ø14 Rail
00887517650726PEEK Corp Endcap, 19x16x15 Lord Ø14 Rail
00887517650719PEEK Corp Endcap, 17x15x15 Lord Ø14 Rail
00887517650702PEEK Corp Endcap, 22x19x15 Lord Ø14 Rail
00887517650696PEEK Corp Endcap, 19x16x10 Lord Ø14 Rail
00887517650689PEEK Corp Endcap, 17x15x10 Lord Ø14 Rail
00887517650672PEEK Corp Endcap, 22x19x10 Lord Ø14 Rail
00887517650665PEEK Corp Endcap,17x14 Lord 7° Rail Ø12
00887517650658PEEK Corp Endcap,15x13 Lord 7° Rail Ø12
00887517650641PEEK Corp Endcap,17x14 Lord 15° Rail Ø12
00887517650634PEEK Corp Endcap,15x13 Lord 15° Rail Ø12
00887517650627PEEK Corp Endcap,17x14 Lord 10° Rail Ø12
00887517650610PEEK Corp Endcap,15x13 Lord 10° Rail Ø12
00887517650603PEEK Corp Endcap, 19x16 Para Ø14 Rail
00887517645890PEEK Corp Endcap, 17x15 Para Ø14 Rail
00887517645883PEEK Corp Endcap, 22x19 Para Ø14 Rail
00887517645876PEEK Corp Endcap, 17x14 Para Ø12 Rail
00887517645869PEEK Corp Endcap, 15x13 Para Ø12 Rail
00887517624710PEEK Corp Measurement Tool, Ø14
00887517624703PEEK Corp Measurement Tool, Ø12
00887517624611PEEK Corp Endcap, Ø16 Round/Ø14 Core
00887517624604PEEK Corp Endcap, Ø14 Round/Ø12 Core
00887517624598PEEK Corp Endcap, 19x16x7° Lordotic Ø14
00887517624581PEEK Corp Endcap, 17x15x7° Lordotic Ø14
00887517624574PEEK Corp Endcap, 22x19x7° Lordotic Ø14
00887517624567PEEK Corp Endcap, 19x16x15° Lordotic Ø14
00887517624550PEEK Corp Endcap, 17x15x15° Lordotic Ø14
00887517624543PEEK Corp Endcap, 22x19x15° Lordotic Ø14
00887517624536PEEK Corp Endcap, 19x16x10° Lordotic Ø14
00887517624529PEEK Corp Endcap, 17x15x10° Lordotic Ø14
00887517624512PEEK Corp Endcap, 22x19x10° Lordotic Ø14
00887517624505PEEK Corp Endcap, 17x14x7° Lordotic Ø12
00887517624499PEEK Corp Endcap, 15x13x7° Lordotic Ø12
00887517624482PEEK Corp Endcap, 17x14x15° Lordotic Ø12
00887517624475PEEK Corp Endcap, 15x13x15° Lordotic Ø12
00887517624468PEEK Corp Endcap, 17x14x10° Lordotic Ø12
00887517624451PEEK Corp Endcap, 15x13x10° Lordotic Ø12
00887517624444PEEK Corp Endcap, 19x16 Parallel Ø14
00887517624437PEEK Corp Endcap, 17x15 Parallel Ø14
00887517624420PEEK Corp Endcap, 22x19 Parallel Ø14
00887517624413PEEK Corp Endcap, 17x14 Parallel Ø12
00887517624406PEEK Corp Endcap, 15x13 Parallel Ø12

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