510(k) K212414
K212414 is an FDA 510(k) premarket notification submitted by Ossdsign AB for the device "OSSDSIGN Cranial PSI". The FDA issued a decision of Substantially Equivalent on October 1, 2021. 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 1, 2021
- Date Received
- August 3, 2021
- 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.