FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇭 Switzerland
DRILL GUIDE ATTACHMENT (PN 3105 DG) OF THE SODEM HIGH SPEED SYSTEM (PNEUMATIC)
K Number: K023066
·
Decision Nov 25, 2002
Classifications
1
FEI Numbers
37
Registration Numbers
37
Same Product Code
25
Applicant Total
6
Review Days
70
Basic Information
- Device Name
- DRILL GUIDE ATTACHMENT (PN 3105 DG) OF THE SODEM HIGH SPEED SYSTEM (PNEUMATIC)
- K Number
- K023066
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4370
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- SODEM SYSTEMS
- Date Received
- September 16, 2002
- Decision Date
- November 25, 2002
- Product Code
- HBB
- 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 |
|---|---|---|---|
| HBB | Motor, Drill, Pneumatic | FDA class 2 | Neurology |
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Other Clearances by SODEM SYSTEMS
| K Number | Device Name | ||
|---|---|---|---|
| K023070 | SODEM HIGH SPEED SYSTEM (PNEUMATIC) | Jan 28, 2003 | Substantially Equivalent |
| K012457 | SODEM HIGH SPEED SYSTEM (ELECTRIC) (NEURO/SPINE SURGERY) | Oct 22, 2001 | Substantially Equivalent |
| K012453 | SODEM HIGH SPEED SYSTEM (ELECTRIC) (GENERAL ORTHOPEDICS & PLASTIC SURGERY) | Oct 22, 2001 | Substantially Equivalent |
| K012456 | SODEM HIGH SPEED SYSTEM (ELECTRIC) (EAR, NOSE, AND THROAT) | Sep 21, 2001 | Substantially Equivalent |
| K994175 | MODIFICATION TO SODEM HIGH SPEED SYSTEM FOR NEUROSURGICAL USE | Dec 21, 1999 | Substantially Equivalent |