DB-Orthopedics— 510(k) K200752
Substantially EquivalentDimensional Bioceramics, LLC
FDA 510(k) clearance K200752 for DB-Orthopedics, Substantially Equivalent on 2020-04-22. Applicant: Dimensional Bioceramics, LLC. Device class: 2.
Clearance details
- Applicant
- Dimensional Bioceramics, LLC
- 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
- Santa Cruz, CA, US
Recent devices under product code MQV
view all- K260364 — Device 300419 Strip
- K252797 — JAZBI Resorbable Bone Void Filler
- K261008 — Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip +7 more
- K253524 — Adaptos®Fuse Bone Graft
- K253147 — FIBERGRAFT BG Putty GPS Bone Graft Substitute FIBERGRAFT BG Putty Bone Graft Substitute FIBERGRAFT AERIDYAN Matrix Bone Graft Substitute FIBERGRAFT BG Matrix Bone Graft Substitute
More clearances from Dimensional Bioceramics, LLC
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.