FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ARTISAN SPACE MAINTENANCE SYSTEM
K Number: K120271
·
Decision May 30, 2012
Classifications
1
FEI Numbers
106
Registration Numbers
106
Same Product Code
291
Applicant Total
171
Review Days
121
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Basic Information
- Device Name
- ARTISAN SPACE MAINTENANCE SYSTEM
- K Number
- K120271
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.4760
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medtronic Sofamor Danek USA, Inc.
- Date Received
- January 30, 2012
- Decision Date
- May 30, 2012
- Product Code
- JEY
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- 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 |
|---|---|---|---|
| JEY | Plate, Bone | FDA class 2 | Dental |
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