SLIMPLICITY SOLO ANTERIOR CERVICAL PLATE SYSTEM

Appliance, Fixation, Spinal Intervertebral Body

SPINAL USA LLC

The following data is part of a premarket notification filed by Spinal Usa Llc with the FDA for Slimplicity Solo Anterior Cervical Plate System.

Pre-market Notification Details

Device IDK112748
510k NumberK112748
Device Name:SLIMPLICITY SOLO ANTERIOR CERVICAL PLATE SYSTEM
ClassificationAppliance, Fixation, Spinal Intervertebral Body
Applicant SPINAL USA LLC 2050 Executive Dr Pearl,  MS  39208
ContactFrankie Cummins
CorrespondentFrankie Cummins
SPINAL USA LLC 2050 Executive Dr Pearl,  MS  39208
Product CodeKWQ  
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-09-21
Decision Date2012-07-11
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00840019936217 K112748 000
00815362021620 K112748 000
00815362021637 K112748 000
00815362021651 K112748 000
00815362021705 K112748 000
00815362021729 K112748 000
00815362021088 K112748 000
00815362021095 K112748 000
00815362021101 K112748 000
00815362021118 K112748 000
00815362021613 K112748 000
00815362021606 K112748 000
00815362021590 K112748 000
00815362021507 K112748 000
00815362021514 K112748 000
00815362021521 K112748 000
00815362021538 K112748 000
00815362021545 K112748 000
00815362021552 K112748 000
00815362021569 K112748 000
00815362021576 K112748 000
00815362021583 K112748 000
00815362021125 K112748 000
00815362021132 K112748 000
00815362021262 K112748 000
00815362021279 K112748 000
00815362021286 K112748 000
00815362021293 K112748 000
00815362021309 K112748 000
00815362021316 K112748 000
00815362021323 K112748 000
00815362021330 K112748 000
00815362021347 K112748 000
00815362021255 K112748 000
00815362021248 K112748 000
00815362021231 K112748 000
00815362021149 K112748 000
00815362021156 K112748 000
00815362021163 K112748 000
00815362021170 K112748 000
00815362021187 K112748 000
00815362021194 K112748 000
00815362021200 K112748 000
00815362021217 K112748 000
00815362021224 K112748 000
00815362021354 K112748 000

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