Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation
The Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation is a resorbable calcium salt material delivered into traumatic or surgically created bone defects that are not intrinsic to the structural stability of bone; it resorbs over time and is replaced by natural bone. Classified as FDA Class 2 under regulation 21 CFR 888.3045 within the Orthopedic medical specialty, it requires a 510(k) premarket notification and is explicitly not intended for screw augmentation. The product code is OIS. It is flagged as an implant device.
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Basic Information
- Product Code
- OIS
- Device Class
- FDA class 2
- Regulation Number
- 888.3045
- Medical Specialty
- Orthopedic
- Review Panel
- OR
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K073303 | NORIAN DRILLABLE | Jul 02, 2008 | Unknown | Synthes (Usa) |
FEI Numbers
This FDA classification entry is associated with 13 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 13 registration numbers. Click on an entry to view related FDA registrations.