Cranial PSI— 510(k) K161090
Substantially EquivalentOssdsign AB
FDA 510(k) clearance K161090 for Cranial PSI, Substantially Equivalent on 2017-01-19. Applicant: Ossdsign AB. Device class: 2.
Clearance details
- Applicant
- Ossdsign AB
- Product code
- Code GXN
- Device class
- Class 2
- Regulation
- 21 CFR 882.5330
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Uppsala, SE
Recent devices under product code GXN
view allMore clearances from Ossdsign AB
view all- K232315 — Catalyst Bone Void Filler
- K212414 — OSSDSIGN Cranial PSI
- 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
- K181539 — OSSDSIGN Cranioplug
- K140309 — CRANIOPLUG
Adverse events under product code GXN
product code GXN- Injury
- 208
- Total
- 208
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.