ReBOSSIS85
FDA 510(k) clearance K170620 · decided 2017-06-23
Clearance details
- K-number
- K170620
- Device name
- ReBOSSIS85
- Applicant
- Orthorebirth Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2017-03-01
- Decision date
- 2017-06-23
- Days to decision
- 114 days
- Clearance type
- Traditional
- Product code
- MQV
- Device class
- 2
- Regulation number
- 888.3045
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Yokohama, JP
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| BioCera Fibers, Bioresorbable Bone Void Filler, REF: ORB-0320C-KC, ORB-0310C-KC, ORB-0304C recall (Z-2131-2026) | Orthorebirth Co Ltd | 2026-05-07 |
| ZENBONE, REF: ORB-0320C-Z, ORB-0310C-Z, ORB-0304C-Z recall (Z-2132-2026) | Orthorebirth Co Ltd | 2026-05-07 |