510(k) K190523
K190523 is an FDA 510(k) premarket notification submitted by Ossdsign AB for the device "Cranial PSI Accessory Anatomical Model Original, Cranial PSI Accessory Anatomical Model Modified, Cranial PSI Accessory Plastic Drawing Guide, Cranial PSI Accessory Cranial Implant Trial". The FDA issued a decision of Substantially Equivalent on October 10, 2019. The device falls under product code PJN (Filler, Bone Void, Non-Alterable Compound For Cranioplasty), a Class II device regulated under 21 CFR 882.5330. Ossdsign AB has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 10, 2019
- Date Received
- March 4, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Filler, Bone Void, Non-Alterable Compound For Cranioplasty
- Device Class
- Class II
- Regulation Number
- 882.5330
- Review Panel
- NE
- Submission Type
A nonalterable cranial bone void filler is a device that is created from patient-specific computerized tomography (CT) imaging data and intended to fill 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 materials used (e.g., metals, polyether ether ketone (PEEK), etc.) in the construction of the nonalterable cranial bone void fillers are not resorbable and cannot be altered or reshaped at the time of surgery or after implantation without changing the chemical behavior of the material.