510(k) K111077

Device: ORTHOSORB RESORBABLE PINS
Applicant: DEPUY ORTHOPAEDICS, INC.
510(k) number: K111077
Product code: OVZ
Decision: Substantially Equivalent (SESE)
Decision date: 2011-07-12
Date received: 2011-04-18
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: SUZANA OTANO
Address: 700 Orthopaedic Dr. Warsaw IN US 46581 46581

FDA Registration Numbers#

1825034

Source Documents#

Other 510(k) Records For Product Code OVZ #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K140625	ORTHOSORB LS	Biomet, Inc.	2014-04-18
K901456	ORTHOSORB(R) ABSORBABLE PIN	Johnson & Johnson International	1990-08-15

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