Product code OVZ— Orthopedic

ORTHOSORB LS

Classification name: Pin, Fixation, Resorbable, Hard Tissue
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Total cleared: 3
First cleared: 1990-08-15
Most recent: 2014-04-18

FDA classification definition

“Intended for small bone fixation in fracture, osteotomy, and arthrodesis applications.”
— U.S. Food and Drug Administration, device classification record for product code OVZ under 21 CFR 888.3040, via openFDA

Market context for product code OVZ

FDA has cleared 3 devices under product code OVZ between 1990 and 2014, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

20141 clearance
20111 clearance
19901 clearance

Top applicants under product code OVZ

Johnson & Johnson International1 clearance
DePuy Orthopaedics, Inc.1 clearance
Biomet, Inc.1 clearance

Recent clearances under product code OVZ

K140625 — ORTHOSORB LSBiomet, Inc.·2014-04-18
K111077 — ORTHOSORB RESORBABLE PINSDePuy Orthopaedics, Inc.·2011-07-12
K901456 — ORTHOSORB(R) ABSORBABLE PINJohnson & Johnson International·1990-08-15

Data sourced from openFDA. This site is unofficial and independent of the FDA.