JDT · Cap, Bone
Orthopedic · 21 CFR 888.3000 · Class 1
Overview
| Product Code | JDT |
|---|---|
| Device Name | Cap, Bone |
| Regulation | 21 CFR 888.3000 |
| Device Class | Class 1 |
| Review Panel | Orthopedic |
| Implant | Yes |
Identification
A bone cap is a mushroom-shaped device intended to be implanted made of either silicone elastomer or ultra-high molecular weight polyethylene. It is used to cover the severed end of a long bone, such as the humerus or tibia, to control bone overgrowth in juvenile amputees.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.
Cleared Devices (0)
No cleared devices on record.
