FDA 510(k)
FDA class 2
Substantially Equivalent
🇸🇪 Sweden
Cranial PSI
K Number: K161090
·
Decision Jan 19, 2017
Classifications
1
FEI Numbers
45
Registration Numbers
45
Same Product Code
55
Applicant Total
6
Review Days
276
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Basic Information
- Device Name
- Cranial PSI
- K Number
- K161090
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5330
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ossdsign AB
- Date Received
- April 18, 2016
- Decision Date
- January 19, 2017
- Product Code
- GXN
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GXN | Plate, Cranioplasty, Preformed, Non-Alterable | FDA class 2 | Neurology |
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Other Clearances by Ossdsign AB
| K Number | Device Name | ||
|---|---|---|---|
| K232315 | Catalyst Bone Void Filler | Sep 15, 2023 | Substantially Equivalent |
| K212414 | OSSDSIGN Cranial PSI | Oct 1, 2021 | Substantially Equivalent |
| 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 | Oct 10, 2019 | Substantially Equivalent |
| K181539 | OSSDSIGN Cranioplug | Oct 12, 2018 | Substantially Equivalent |
| K140309 | CRANIOPLUG | Oct 3, 2014 | Substantially Equivalent |