QAC
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Screw Sleeve Bone Fixation Device
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3043
- Medical specialty
- Orthopedic
- Flags
- Implant
- FDA definition
- A screw sleeve bone fixation device is intended to be implanted in conjunction with a non-resorbable, metallic bone screw where the screw has lost purchase due to loosening, backout, or breakage. The device fits between the screw threads and surrounding bone, and provides increased surface area to create an interference fit to restore stability of the implant construct.
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| Record | Firm | Date | Builder |
|---|---|---|---|
| OGmend Implant System (DEN180065) | Woven Orthopedic Technologies, LLC | 2020-05-01 |
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