FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ZIMMER COMPUTER ASSISTED SOLUTIONS-ELECTROMAGNETIC AND IMAGELESS KNEE INSTRUMENTATION
K Number: K052425
·
Decision Dec 28, 2005
Classifications
1
FEI Numbers
250
Registration Numbers
250
Same Product Code
422
Applicant Total
376
Review Days
117
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Basic Information
- Device Name
- ZIMMER COMPUTER ASSISTED SOLUTIONS-ELECTROMAGNETIC AND IMAGELESS KNEE INSTRUMENTATION
- K Number
- K052425
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4560
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Zimmer, Inc.
- Date Received
- September 2, 2005
- Decision Date
- December 28, 2005
- 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 |
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