BOVINE PERICARDIUM SUTURABLE DURAL GRAFT, TUTOPATCH DM GRAFT, TUTOPLAST BOVINE PERICARDIUM DM— 510(k) K132850
Substantially EquivalentRti Surgical, Inc.
FDA 510(k) clearance K132850 for BOVINE PERICARDIUM SUTURABLE DURAL GRAFT, TUTOPATCH DM GRAFT, TUTOPLAST BOVINE PERICARDIUM DM, Substantially Equivalent on 2014-03-31. Applicant: Rti Surgical, Inc.. Device class: 2.
Clearance details
- Applicant
- Rti Surgical, Inc.
- Product code
- Code GXQ
- Device class
- Class 2
- Regulation
- 21 CFR 882.5910
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Alachua, FL, US
Recent devices under product code GXQ
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 GXQ
product code GXQ- Death
- 11
- Injury
- 446
- Other
- 1
- Total
- 458
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.