Periacetabular Osteotomy System 01-1401-0002

GUDID 00841132128725

OFFSET CURVED OSTEOTOME, RIGHT

ORTHOPEDIATRICS CORP.

Orthopaedic surgical procedure kit, non-medicated, reusable
Primary Device ID00841132128725
NIH Device Record Keyf3aaf29c-8c17-448b-9308-3fb5dc0f5ce2
Commercial Distribution StatusIn Commercial Distribution
Brand NamePeriacetabular Osteotomy System
Version Model Number01-1401-0002
Catalog Number01-1401-0002
Company DUNS796416191
Company NameORTHOPEDIATRICS CORP.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
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
GS100841132128725 [Primary]

FDA Product Code

HWMOSTEOTOME

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-10-31

On-Brand Devices [Periacetabular Osteotomy System]

00841132128756PAO TRAY LID
00841132128749PAO TRAY
00841132128732DUAL-SPIKED PUBIS RETRACTOR
00841132128725OFFSET CURVED OSTEOTOME, RIGHT
00841132128718OFFSET CURVED OSTEOTOME, LEFT
00840194478502Single Point Offset Pubis Retractor
00840194478403PAO Special Pubis Retractor

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