FORTIVA PORCINE DERMIS, TUTOPLAST PORCINE DERMIS— 510(k) K142070
Substantially EquivalentRti Surgical, Inc.
FDA 510(k) clearance K142070 for FORTIVA PORCINE DERMIS, TUTOPLAST PORCINE DERMIS, Substantially Equivalent on 2014-10-27. Applicant: Rti Surgical, Inc.. Device class: 2.
Clearance details
- Applicant
- Rti Surgical, Inc.
- Product code
- Code FTM
- Device class
- Class 2
- Regulation
- 21 CFR 878.3300
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Alachua, FL, US
Recent devices under product code FTM
view allMore clearances from Rti Surgical, Inc.
view all- K253145 — Pre-Sutured Tendon
- K241555 — Moldable Bone Void Filler and Moldable Bone Void Filler + CCC
- 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
Adverse events under product code FTM
product code FTM- Death
- 17
- Injury
- 2,174
- Total
- 2,191
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.