ReBOSSIS85— 510(k) K170620
Substantially EquivalentOrthorebirth Co., Ltd.
FDA 510(k) clearance K170620 for ReBOSSIS85, Substantially Equivalent on 2017-06-23. Applicant: Orthorebirth Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Orthorebirth Co., Ltd.
- Product code
- Code MQV
- Device class
- Class 2
- Regulation
- 21 CFR 888.3045
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Yokohama, JP
Recent devices under product code MQV
view allMore clearances from Orthorebirth Co., Ltd.
view allAdverse events under product code MQV
product code MQV- Death
- 6
- Injury
- 435
- Total
- 441
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K170620
K-number listed on FDA's recall record- Z-2131-2026 — BioCera Fibers, Bioresorbable Bone Void Filler, REF: ORB-0320C-KC, ORB-0310C-KC, ORB-0304C-KC, ORB-0302C-KC, ORB-0305D-KC
- Z-2132-2026 — ZENBONE, REF: ORB-0320C-Z, ORB-0310C-Z, ORB-0304C-Z
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K170620.
Data sourced from openFDA. This site is unofficial and independent of the FDA.