PJM — Filler, Bone Void, Alterable Compound For Cranioplasty Class II
FDA product code PJM covers "Filler, Bone Void, Alterable Compound For Cranioplasty", a Class II medical device regulated under 21 CFR 882.5320. Submissions are reviewed by the Neurology panel. Devices under this code are implants.
Classification Details
- Product Code
- PJM
- Device Class
- Class II
- Regulation Number
- 882.5320
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- Yes
Definition
An alterable cranial bone void filler is a device intended to be a bone substitute for the replacement of bony voids, defects, and contour irregularities in non-load bearing regions of the cranial skeleton, and are not intrinsic to the stability of the bony structure. The device is constructed from a material (e.g., calcium, polymer synthetic-based, etc.) that can be reshaped or altered at the time of surgery or after implantation without changing the chemical behavior of the material.