FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
ZMM 2000 ZEPPELIN MILLENNIUM MOTORDRILL SYSTEM
K Number: K013091
·
Decision Jan 25, 2002
Classifications
1
FEI Numbers
46
Registration Numbers
46
Same Product Code
26
Applicant Total
5
Review Days
130
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Basic Information
- Device Name
- ZMM 2000 ZEPPELIN MILLENNIUM MOTORDRILL SYSTEM
- K Number
- K013091
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4370
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Von Zeppelin GmbH
- Date Received
- September 17, 2001
- Decision Date
- January 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 Von Zeppelin GmbH
| K Number | Device Name | ||
|---|---|---|---|
| K954658 | PERNECZKY CLIP APPLIER/REMOVER | Oct 8, 1996 | Substantially Equivalent |
| K903151 | INTERVERTEBRAL DISC RONGEUR | Dec 11, 1990 | Substantially Equivalent |
| K901312 | PERNECZKY ANEURYSM CLIP | Aug 17, 1990 | Substantially Equivalent |
| K901313 | INSTRUMENTS FOR NEUROLOGICAL SURGERY | Jul 23, 1990 | Substantially Equivalent |