GE HEALTHCARE INSTA TRAK 3500PLUS/ FLUORO TRAK 9800 PLUS SYSTEM WITH AXCESS BONE PIN, MODEL PART # 1006955
FDA 510(k) clearance K051734 · decided 2005-11-23
Clearance details
- K-number
- K051734
- Device name
- GE HEALTHCARE INSTA TRAK 3500PLUS/ FLUORO TRAK 9800 PLUS SYSTEM WITH AXCESS BONE PIN, MODEL PART # 1006955
- Applicant
- Ge Healthcare Technologies
- Decision
- Substantially Equivalent
- Date received
- 2005-06-28
- Decision date
- 2005-11-23
- Days to decision
- 148 days
- Clearance type
- Traditional
- Product code
- HAW
- Device class
- 2
- Regulation number
- 882.4560
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Lawrence, MA, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| The Axcess Cranial Screw (sometimes referred to as the Axcess Cranial Pin) is a self-tappi recall (Z-1989-2012) | GE OEC Medical Systems, Inc | 2012-07-11 |