Gibralt® Spine System And Gibralt® Occipital Spine System

Posterior Cervical Screw System

Exactech, Inc.

The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Gibralt® Spine System And Gibralt® Occipital Spine System.

Pre-market Notification Details

Device IDK160697
510k NumberK160697
Device Name:Gibralt® Spine System And Gibralt® Occipital Spine System
ClassificationPosterior Cervical Screw System
Applicant Exactech, Inc. 2320 NW 66th Court Gainesville,  FL  32653
ContactDawn Davisson
CorrespondentKenneth C. Maxwell
Empirical Testing Corp. 4628 Northpark Drive Colorado Springs,  CO  80918
Product CodeNKG  
CFR Regulation Number888.3075 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-03-14
Decision Date2016-06-28
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00840996170017 K160697 000
00840996169936 K160697 000
00840996169943 K160697 000
00840996169950 K160697 000
00840996169967 K160697 000
00840996169974 K160697 000
00840996169981 K160697 000
00840996169998 K160697 000
00840996170000 K160697 000
00840996169929 K160697 000

Trademark Results [Gibralt]

Mark Image

Registration | Serial
Company
Trademark
Application Date
GIBRALT
GIBRALT
88578157 not registered Live/Pending
Pfizer Inc.
2019-08-14
GIBRALT
GIBRALT
87125959 not registered Live/Pending
Agouron Pharmaceuticals, LLC
2016-08-03
GIBRALT
GIBRALT
85831543 not registered Dead/Abandoned
AGOURUN PHARMACEUTICALS, LLC
2013-01-24
GIBRALT
GIBRALT
78971429 not registered Dead/Abandoned
Agouron Pharmaceuticals, Inc.
2006-09-11
GIBRALT
GIBRALT
78233093 not registered Dead/Abandoned
Agouron Pharmaceuticals, Inc.
2003-04-02
GIBRALT
GIBRALT
77895757 4102820 Live/Registered
Exactech, Inc.
2009-12-17
GIBRALT
GIBRALT
77766031 not registered Dead/Abandoned
Agouron Pharmaceuticals, Inc.
2009-06-23

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