Catalyst Bone Void Filler
FDA 510(k) clearance K232315 · decided 2023-09-15
Clearance details
- K-number
- K232315
- Device name
- Catalyst Bone Void Filler
- Applicant
- Ossdsign AB
- Decision
- Substantially Equivalent
- Date received
- 2023-08-02
- Decision date
- 2023-09-15
- Days to decision
- 44 days
- Clearance type
- Traditional
- Product code
- MQV
- Device class
- 2
- Regulation number
- 888.3045
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Uppsala, IE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.