Streamline TL Spinal Fixation System— 510(k) K192800
Substantially EquivalentPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)
FDA 510(k) clearance K192800 for Streamline TL Spinal Fixation System, Substantially Equivalent on 2020-01-14. 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 NKB
- Device class
- Class 2
- Regulation
- 21 CFR 888.3070
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Marquette, MI, US
Recent devices under product code NKB
view all- K262828 — KHEIRON® Spinal Fixation System, including patient specific K-ROD
- K253943 — Tiger 2 System
- K260362 — QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration)
- K261284 — Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System
- K253802 — KHEIRON® Spinal Fixation System, including patient specific K-ROD
More clearances from Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)
view all- K201497 — EVOS Cabling System
- K200095 — Streamline Navigated Instruments
- K193468 — Tritium Sternal Cable Plate System
- K192718 — Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D Technology
- K190498 — Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs: Fortilink®-TS IBF System, Fortilink®-L I BF System, Fortilink®-C IBF System
Adverse events under product code NKB
product code NKB- Death
- 27
- Injury
- 5,033
- Malfunction
- 4,140
- Total
- 9,200
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.