510(k) K901456

Device
ORTHOSORB(R) ABSORBABLE PIN
Applicant
JOHNSON & JOHNSON INTERNATIONAL
510(k) number
K901456
Product code
OVZ  
Decision
Substantially Equivalent (SESE)
Decision date
1990-08-15
Date received
1990-03-27
Regulation
888.3040
Classification name
Pin, Fixation, Resorbable, Hard Tissue
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
MARSHA J STONE
Address
100 Bay State Dr. Braintree MA US 02184 02184

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code OVZ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K140625ORTHOSORB LSBiomet, Inc.2014-04-18
K111077ORTHOSORB RESORBABLE PINSDePuy Orthopaedics, Inc.2011-07-12

Legacy Summary#

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FDA Review#

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