FDA Product Code
FDA Product Code PJN — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Neurology
- 21 CFR Citation
- 882.5330
510(k) Clearances — 2 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K212414 | OSSDSIGN Cranial PSI | Ossdsign AB | 2021-10-01 | Traditional | PDF ↗ |
| 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 | Ossdsign AB | 2019-10-10 | Traditional | PDF ↗ |
Product code PJN · Class II · Neurology. Data: openFDA.