510(k) K212414
- Device
- OSSDSIGN Cranial PSI
- Applicant
- OssDsign AB
- 510(k) number
- K212414
- Product code
- PJN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-10-01
- Date received
- 2021-08-03
- Regulation
- 882.5330
- Classification name
- Filler, Bone Void, Non-alterable Compound For Cranioplasty
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Ulrik Birgersson
- Address
- Rapsgatan 23 A Uppsala SE SE 754 50 SE 754 50
FDA Registration Numbers#
- 1064858
- 3014680740
- 3015259858
- 3006130229
- 3010407203
Source Documents#
Other 510(k) Records For Product Code PJN #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
Legacy Summary#
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FDA Review#
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