OIS · Class II · 21 CFR 888.3045

FDA Product Code OIS: Calcium Salt Bone Void Filler, Drillable, Non-screw Augmentation

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.

Leading manufacturers include Synthes (Usa).

Total

Cleared

222d

Avg days

2008

Since

FDA 510(k) Cleared Calcium Salt Bone Void Filler, Drillable, Non-screw Augmentation Devices (Product Code OIS)

1 devices

1–1 of 1

About Product Code OIS - Regulatory Context

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Data Source

FDA 510(k) public files . 175,218 total devices indexed.

Latest clearance: Jul 02, 2008

Product Code Info

Code	OIS
Device class	Class II
CFR	21 CFR 888.3045
Panel	Orthopedic

Verify on FDA.gov

View OIS classification on FDA.gov →