GE HEALTHCARE INSTA TRAK 3500PLUS/ FLUORO TRAK 9800 PLUS SYSTEM WITH AXCESS BONE PIN, MODEL PART # 1006955— 510(k) K051734
Substantially EquivalentGe Healthcare Technologies
FDA 510(k) clearance K051734 for GE HEALTHCARE INSTA TRAK 3500PLUS/ FLUORO TRAK 9800 PLUS SYSTEM WITH AXCESS BONE PIN, MODEL PART # 1006955, Substantially Equivalent on 2005-11-23. Applicant: Ge Healthcare Technologies. Device class: 2.
Clearance details
- Applicant
- Ge Healthcare Technologies
- 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
- Lawrence, MA, US
Recent devices under product code HAW
view allMore clearances from Ge Healthcare Technologies
view allAdverse 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 K051734
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K051734.
Data sourced from openFDA. This site is unofficial and independent of the FDA.