ORTHOPEDIC SALVAGE SYSTEM (OSS™) / ARCOS® 110024552

GUDID 00880304683068

Biomet Orthopedics, LLC

Instrument tray Instrument tray Instrument tray Instrument tray Instrument tray Instrument tray Instrument tray Instrument tray Instrument tray Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable
Primary Device ID00880304683068
NIH Device Record Keybfbe6207-9150-409b-a9bd-6cdb8062bf11
Commercial Distribution StatusIn Commercial Distribution
Brand NameORTHOPEDIC SALVAGE SYSTEM (OSS™) / ARCOS®
Version Model Number110024552
Catalog Number110024552
Company DUNS129278169
Company NameBiomet Orthopedics, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100880304683068 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JDIProsthesis, hip, semi-constrained, metal/polymer, cemented

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00880304683068]

Moist Heat or Steam Sterilization


[00880304683068]

Moist Heat or Steam Sterilization


[00880304683068]

Moist Heat or Steam Sterilization


[00880304683068]

Moist Heat or Steam Sterilization


[00880304683068]

Moist Heat or Steam Sterilization


[00880304683068]

Moist Heat or Steam Sterilization


[00880304683068]

Moist Heat or Steam Sterilization


[00880304683068]

Moist Heat or Steam Sterilization


[00880304683068]

Moist Heat or Steam Sterilization


[00880304683068]

Moist Heat or Steam Sterilization


[00880304683068]

Moist Heat or Steam Sterilization


[00880304683068]

Moist Heat or Steam Sterilization


[00880304683068]

Moist Heat or Steam Sterilization


[00880304683068]

Moist Heat or Steam Sterilization


[00880304683068]

Moist Heat or Steam Sterilization


[00880304683068]

Moist Heat or Steam Sterilization


[00880304683068]

Moist Heat or Steam Sterilization


[00880304683068]

Moist Heat or Steam Sterilization


[00880304683068]

Moist Heat or Steam Sterilization


[00880304683068]

Moist Heat or Steam Sterilization


[00880304683068]

Moist Heat or Steam Sterilization


[00880304683068]

Moist Heat or Steam Sterilization


[00880304683068]

Moist Heat or Steam Sterilization


[00880304683068]

Moist Heat or Steam Sterilization


[00880304683068]

Moist Heat or Steam Sterilization


[00880304683068]

Moist Heat or Steam Sterilization


[00880304683068]

Moist Heat or Steam Sterilization


[00880304683068]

Moist Heat or Steam Sterilization


[00880304683068]

Moist Heat or Steam Sterilization


[00880304683068]

Moist Heat or Steam Sterilization


[00880304683068]

Moist Heat or Steam Sterilization


[00880304683068]

Moist Heat or Steam Sterilization


[00880304683068]

Moist Heat or Steam Sterilization


[00880304683068]

Moist Heat or Steam Sterilization


[00880304683068]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-08-09
Device Publish Date2018-10-19

On-Brand Devices [ORTHOPEDIC SALVAGE SYSTEM (OSS™) / ARCOS®]

00880304683068110024552
00887868347795110028036
00887868347788110027910
00887868347771110024564
00887868347764110024563
00887868347757110024562
00887868347740110024561
00887868347733110024560
00887868347726110024559
00887868347719110024558
00887868347702110024557
00887868347696110024556
00887868347689110024555
00887868347672110024554

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