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
- Product 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 allMore 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.