FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇪 Ireland
Catalyst Bone Void Filler
K Number: K232315
·
Decision Sep 15, 2023
Classifications
1
FEI Numbers
234
Registration Numbers
234
Same Product Code
483
Applicant Total
4
Review Days
44
Basic Information
- Device Name
- Catalyst Bone Void Filler
- K Number
- K232315
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3045
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- OssDsign AB
- Date Received
- August 2, 2023
- Decision Date
- September 15, 2023
- Product Code
- MQV
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- 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 |
|---|---|---|---|
| MQV | Filler, Bone Void, Calcium Compound | FDA class 2 | Orthopedic |
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Other Clearances by OssDsign AB
| K Number | Device Name | ||
|---|---|---|---|
| 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 |