OIS — Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation Class II
FDA product code OIS covers "Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation", a Class II medical device regulated under 21 CFR 888.3045. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- OIS
- Device Class
- Class II
- Regulation Number
- 888.3045
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K073303 | synthes (usa) | NORIAN DRILLABLE | July 2, 2008 |