NAVITRACK SYSTEM- PARTIAL HIP RESURFACING UNIVERSAL— 510(k) K071929
Substantially EquivalentOrthosoft, Inc.
FDA 510(k) clearance K071929 for NAVITRACK SYSTEM- PARTIAL HIP RESURFACING UNIVERSAL, Substantially Equivalent on 2007-09-19. Applicant: Orthosoft, Inc.. Device class: 2.
Clearance details
- Applicant
- Orthosoft, Inc.
- Product code
- Code HAW
- Device class
- Class 2
- Regulation
- 21 CFR 882.4560
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Montreal, CA
Recent devices under product code HAW
view allMore clearances from Orthosoft, Inc.
view all- K131409 — CAS PSI KNEE SYSTEM
- K100599 — CAS FIXATION PIN 3.2 DIA X 180 MM STR, CAS FIXATON PIN 3.2 DIA X 80 MM STR, CAS FIXATON PIN 3.2 DIA X 150 MM
- K071714 — NAVITRACK SYSTEM - OS UNICONDYLAR KNEE UNIVERSAL, MODEL# PRO-06003
- K060336 — NAVITRACK SYSTEM-OS KNEE UNIVERSAL, MODEL PRO-05002
- K043536 — NAVITRACK SYSTEM - S&N IMAGE FREE KNEE
Adverse events under product code HAW
product code HAW- Death
- 52
- Injury
- 1,083
- Malfunction
- 17,300
- Total
- 18,435
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 →
Recalls naming K071929
K-number listed on FDA's recall record- Z-2048-2017 — NDI P7 Position Sensor, Stereotaxic Instrument
- Z-2227-2017 — Sesamoid Plasty, Stereotaxic Instrument The Sesamoid Plasty workstation is used to run the tracking software as part of the software based navigation systems. The affected Sesamoid Plasty components are the central structural column and its base that hold up the computer and the tracking camera on the Sesamoid Plasty workstation. They are also designed to be disassembled such that the column can be folded onto itself for ease of transport after use. This is a retrospective recall report for a removal initiated on 17 June 2008
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K071929.
Data sourced from openFDA. This site is unofficial and independent of the FDA.