FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
STERILE STORM (R) OPERATING KIT
K Number: K111001
·
Decision May 17, 2011
Classifications
1
FEI Numbers
653
Registration Numbers
653
Same Product Code
1040
Applicant Total
3
Review Days
36
Basic Information
- Device Name
- STERILE STORM (R) OPERATING KIT
- K Number
- K111001
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- INTELLIGENT ORTHOPAEDICS LTD
- Date Received
- April 11, 2011
- Decision Date
- May 17, 2011
- Product Code
- HWC
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- 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 |
|---|---|---|---|
| HWC | Screw, Fixation, Bone | FDA class 2 | Orthopedic |
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