OrthoPediatrics ACL Reconstruction System 10-1008-1090

GUDID 00841132122174

ArmorLink 9.0mm

ORTHOPEDIATRICS CORP.

Ligament bone anchor
Primary Device ID00841132122174
NIH Device Record Keyef5a140b-9043-403e-8dcb-452881b25f40
Commercial Distribution StatusIn Commercial Distribution
Brand NameOrthoPediatrics ACL Reconstruction System
Version Model Number10-1008-1090
Catalog Number10-1008-1090
Company DUNS796416191
Company NameORTHOPEDIATRICS CORP.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
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(574)268-6379
EmailRbremer@orthopediatrics.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100841132122174 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MBIFASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00841132122174]

Radiation Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-01-08
Device Publish Date2015-09-18

On-Brand Devices [OrthoPediatrics ACL Reconstruction System]

00841132122242ShieldLoc 8.5mm
00841132122235ShieldLoc 8.0mm
00841132122228ShieldLoc 7.5mm
00841132122211ShieldLoc 7.0mm
00841132122204ShieldLoc 6.5mm
00841132122198ShieldLoc 6.0mm
00841132122181ArmorLink 10.0mm
00841132122174ArmorLink 9.0mm
00841132122167ArmorLink 8.5mm
00841132122150ArmorLink 8.0mm
00841132122143ArmorLink 7.5mm
00841132122136ArmorLink 7.0mm
00841132122129ArmorLink 6.5mm
00841132122112ArmorLink 6.0mm

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