Moldable Bone Void Filler and Moldable Bone Void Filler + CCC— 510(k) K241555
Substantially EquivalentRti Surgical, Inc.
FDA 510(k) clearance K241555 for Moldable Bone Void Filler and Moldable Bone Void Filler + CCC, Substantially Equivalent on 2025-02-21. Applicant: Rti Surgical, Inc.. Device class: 2.
Clearance details
- Applicant
- Rti Surgical, Inc.
- 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
- Alachua, FL, 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 Rti Surgical, Inc.
view all- K253145 — Pre-Sutured Tendon
- K230036 — Pre-Sutured Tendon (4561SC / Single Strand); Pre-Sutured Tendon (4564SC / Quadruple Strand )
- K172343 — Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D Technology
- K163673 — Fortilink-C with TETRAfuse 3D Technology
- K142070 — FORTIVA PORCINE DERMIS, TUTOPLAST PORCINE DERMIS
Adverse 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.