Orthosorb Resorbable Pins

FDA 510(k) K111077 · DePuy Orthopaedics, Inc.

Substantially Equivalent

510(k) numberK111077

Submission

Device name
Orthosorb Resorbable Pins
Applicant
DePuy Orthopaedics, Inc.
Warsaw, IN, US
Received
April 18, 2011
Decision date
July 12, 2011
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
OVZ – Pin, Fixation, Resorbable, Hard Tissue
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3040
Specialty
Orthopedic
Implant
Yes

Intended for small bone fixation in fracture, osteotomy, and arthrodesis applications.

Other 510(k)s with product code OVZ

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K140625Orthosorb LSOVZ · Traditional Biomet, Inc.04/18/2014SE
K901456Orthosorb(R) Absorbable PinOVZ · Traditional Johnson & Johnson International08/15/1990SE

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Questions and answers

When was Orthosorb Resorbable Pins cleared by the FDA?

Orthosorb Resorbable Pins (K111077) received a 510(k) decision of Substantially Equivalent on July 12, 2011, 85 days after the submission was received.

What is the product code of K111077?

The FDA product code is OVZ – Pin, Fixation, Resorbable, Hard Tissue, a Class II (moderate risk) device regulated under 21 CFR 888.3040.