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510(k) K190523

Cranial PSI Accessory – Anatomical Model Original, Cranial PSI Accessory – Anatomical Model Modified, Cranial PSI Accessory – Plastic Drawing Guide, Cranial PSI Accessory – Cranial Implant Trial by Ossdsign AB — Product Code PJN

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.

Other clearances by Ossdsign AB

  • K232315 — Catalyst Bone Void Filler (September 15, 2023)
  • K212414 — OSSDSIGN Cranial PSI (October 1, 2021)
  • K181539 — OSSDSIGN Cranioplug (October 12, 2018)
  • K161090 — Cranial PSI (January 19, 2017)
  • K140309 — CRANIOPLUG (October 3, 2014)

Other clearances for product code PJN

  • K212414 — OSSDSIGN Cranial PSI (October 1, 2021)