FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INNOVASIS CRANIAL SYSTEM
K Number: K141644
·
Decision Nov 7, 2014
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
41
Applicant Total
33
Review Days
141
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Basic Information
- Device Name
- INNOVASIS CRANIAL SYSTEM
- K Number
- K141644
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5320
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Innovasis, Inc.
- Date Received
- June 19, 2014
- Decision Date
- November 7, 2014
- Product Code
- GWO
- 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 |
|---|---|---|---|
| GWO | Plate, Cranioplasty, Preformed, Alterable | FDA class 2 | Neurology |
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Neuro Plating System, Neuro Plating System Plates(NST304M02A and 61 Models), Neuro Plating System-Packaging unit(NSP-001 and 10 models), Neuro Plating System-Sterile Kit(TCN-011 and 69 models), Neuro Plating System-Screws(N15A03 and 11 models)
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