Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D Technology— 510(k) K192718
Substantially EquivalentPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.
FDA 510(k) clearance K192718 for Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D Technology, Substantially Equivalent on 2019-12-20. Applicant: Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.. Device class: 2.
Clearance details
- Applicant
- Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.
- Product code
- Code MAX
- Device class
- Class 2
- Regulation
- 21 CFR 888.3080
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Marquette, MI, US
Recent devices under product code MAX
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Adverse events under product code MAX
product code MAX- Death
- 13
- Injury
- 1,305
- Malfunction
- 2,885
- Total
- 4,203
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.