FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFICATION TO: STRYKER NAVIGATION SYSTEM, STRYKER FLUOROSCOPY SYSTEM,VIRTUAL FLUOROSCOPY
K Number: K012380
·
Decision Dec 3, 2001
Classifications
1
FEI Numbers
246
Registration Numbers
246
Same Product Code
417
Applicant Total
12
Review Days
130
Basic Information
- Device Name
- MODIFICATION TO: STRYKER NAVIGATION SYSTEM, STRYKER FLUOROSCOPY SYSTEM,VIRTUAL FLUOROSCOPY
- K Number
- K012380
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4560
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- STRYKER LEIBINGER
- Date Received
- July 26, 2001
- Decision Date
- December 3, 2001
- Product Code
- HAW
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HAW | Neurological Stereotaxic Instrument | FDA class 2 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HAW), ordered by most recent decision date.
EZ-FIDUCIALS
FDA 510(k)
FDA Class 2
·Neurology
Stereotaxic Guiding Surgical Devices, NaoTrac S
FDA 510(k)
FDA Class 2
·Neurology
Navient Image Guide Navigation System (955-NC-NC), Cranial
FDA 510(k)
FDA Class 2
·Neurology
Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment Software Cranial Biopsy; Cirq Alignment Software Cranial sEEG; VarioGuide Alignment Software Cranial; Cirq Alignment Software Cranial LITT
FDA 510(k)
FDA Class 2
·Neurology
ClearPoint System (Software Version 3.0)
FDA 510(k)
FDA Class 2
·Neurology
Geniant Cranial (Navigated Neurosurgical Positioning Robot)
FDA 510(k)
FDA Class 2
·Neurology
Other Clearances by STRYKER LEIBINGER
| K Number | Device Name | ||
|---|---|---|---|
| K052871 | STRYKER CUSTOM TI IMPLANT | Dec 16, 2005 | Substantially Equivalent |
| K043250 | STRYKER PATIENT SPECIFIC POLYMER IMPLANT | Apr 15, 2005 | Substantially Equivalent |
| K041651 | STRYKER LEIBINGER SKELETAL ANCHORING SYSTEM | Sep 30, 2004 | Substantially Equivalent |
| K040022 | STRYKER LEIBINGER UNIVERSAL DISTAL RADIUS SYSTEM | Mar 12, 2004 | Substantially Equivalent |
| K022579 | STRYKER NAVIGATION SYSTEM-KNEE MODULE | Jun 2, 2003 | Substantially Equivalent |
| K023449 | NON-INVASIVE PATIENT FIXATION SYSTEM | Jan 13, 2003 | Substantially Equivalent |
| K013775 | TWINFIX INTERFRAGMENTARY COMPRESSION SCREW SYSTEM | Jan 8, 2002 | Substantially Equivalent |
| K000594 | LOCKING SCREW MANDIBULAR RECONSTRUCTION PLATE | Dec 8, 2000 | Substantially Equivalent |
| K000348 | COLORADO MICRODISSECTION NEEDLE | May 3, 2000 | Substantially Equivalent |
| K000349 | MOTORIZED MICRO MULTILEAF COLLIMATOR | May 3, 2000 | Substantially Equivalent |