DeviceClearance

Product code OIS— Orthopedic

NORIAN DRILLABLE

Classification name
Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation
Device class
Class 2
Regulation
21 CFR 888.3045
Advisory panel
Orthopedic
Total cleared
1
First cleared
Most recent

FDA classification definition

“To fill traumatic or surgically-created defects not intrinsic to the stability of the bony structure. It is delivered to the defect and resorbs over time to be replaced by bone. Not for screw augmentation.”

— U.S. Food and Drug Administration, device classification record for product code OIS under 21 CFR 888.3045, via openFDA

Market context for product code OIS

FDA has cleared 1 device under product code OIS, all in 2008, filed by 1 applicant company. 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.

Top applicants under product code OIS

Recent clearances under product code OIS

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