Cranial PSI Accessory – Anatomical Model Original, Cranial PSI Accessory – Anatomical Model Modified, Cranial PSI Accessory – Plastic Drawing Guide, Cranial PSI Accessory – Cranial Implant Trial
FDA 510(k) clearance K190523 · decided 2019-10-10
Clearance details
- K-number
- K190523
- Device name
- Cranial PSI Accessory – Anatomical Model Original, Cranial PSI Accessory – Anatomical Model Modified, Cranial PSI Accessory – Plastic Drawing Guide, Cranial PSI Accessory – Cranial Implant Trial
- Applicant
- Ossdsign AB
- Decision
- Substantially Equivalent
- Date received
- 2019-03-04
- Decision date
- 2019-10-10
- Days to decision
- 220 days
- Clearance type
- Traditional
- Product code
- PJN
- Device class
- 2
- Regulation number
- 882.5330
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Uppsala, SE
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| OSSDSIGN Cranial PSI (K212414) | Ossdsign AB | 2021-10-01 |
Recalls involving this device
No recalls on record reference this clearance.