REFORM PEDICLE SCREW SYSTEM

Orthosis, Spinal Pedicle Fixation

SPINAL USA

The following data is part of a premarket notification filed by Spinal Usa with the FDA for Reform Pedicle Screw System.

Pre-market Notification Details

Device IDK131343
510k NumberK131343
Device Name:REFORM PEDICLE SCREW SYSTEM
ClassificationOrthosis, Spinal Pedicle Fixation
Applicant SPINAL USA 4628 NORTHPARK DRIVE Colorado Springs,  CO  80918
ContactMeredith May
CorrespondentMeredith May
SPINAL USA 4628 NORTHPARK DRIVE Colorado Springs,  CO  80918
Product CodeMNI  
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-05-09
Decision Date2013-07-24
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00815362027417 K131343 000
00815362027400 K131343 000
00815362027394 K131343 000
00815362027387 K131343 000
00815362027370 K131343 000
00815362027363 K131343 000

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