FDA.reportPublic FDA data

510(k) K140625

Device
ORTHOSORB LS
Applicant
BIOMET, INC.
510(k) number
K140625
Product code
OVZ  
Decision
Substantially Equivalent (SESE)
Decision date
2014-04-18
Date received
2014-03-11
Regulation
888.3040
Classification name
Pin, Fixation, Resorbable, Hard Tissue
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
VICTORIA SCHEITLIN
Address
56 E. Bell Dr. Box 587 Warsaw IN US 46581 46581

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code OVZ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K111077ORTHOSORB RESORBABLE PINSDePuy Orthopaedics, Inc.2011-07-12
K901456ORTHOSORB(R) ABSORBABLE PINJohnson & Johnson International1990-08-15

Legacy Summary#

summary

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases