ORTHOPEDIATRICS ACL RECONSTRUCTIVE SYSTEM

Fastener, Fixation, Nondegradable, Soft Tissue

ORTHOPEDIATRICS, CORP.

The following data is part of a premarket notification filed by Orthopediatrics, Corp. with the FDA for Orthopediatrics Acl Reconstructive System.

Pre-market Notification Details

Device IDK130217
510k NumberK130217
Device Name:ORTHOPEDIATRICS ACL RECONSTRUCTIVE SYSTEM
ClassificationFastener, Fixation, Nondegradable, Soft Tissue
Applicant ORTHOPEDIATRICS, CORP. 2850 FRONTIER DRIVE Warsaw,  IN  46582
ContactMark Fox
CorrespondentMark Fox
ORTHOPEDIATRICS, CORP. 2850 FRONTIER DRIVE Warsaw,  IN  46582
Product CodeMBI  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-01-29
Decision Date2013-06-20
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00841132122242 K130217 000
00841132122129 K130217 000
00841132122136 K130217 000
00841132122143 K130217 000
00841132122150 K130217 000
00841132122167 K130217 000
00841132122174 K130217 000
00841132122181 K130217 000
00841132122198 K130217 000
00841132122204 K130217 000
00841132122211 K130217 000
00841132122228 K130217 000
00841132122235 K130217 000
00841132122112 K130217 000

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