NB3D BONE VOID FILLER
FDA 510(k) clearance K132050 · decided 2014-02-07
Clearance details
- K-number
- K132050
- Device name
- NB3D BONE VOID FILLER
- Applicant
- Pioneer Surgical Technology, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-07-02
- Decision date
- 2014-02-07
- Days to decision
- 220 days
- Clearance type
- Traditional
- Product code
- MQV
- Device class
- 2
- Regulation number
- 888.3045
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Marquette, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| nanOss 3D Advanced Bone Graft Substitute nanOss 3D Plus Advanced Bone Graft Substitute 90- recall (Z-1897-2026) | XTANT Medical Holdings, Inc | 2026-04-21 |