FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CHESAPEAKE SPINAL SYSTEM
K Number: K092211
·
Decision Mar 5, 2010
Classifications
1
FEI Numbers
253
Registration Numbers
253
Same Product Code
200
Applicant Total
100
Review Days
226
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Basic Information
- Device Name
- CHESAPEAKE SPINAL SYSTEM
- K Number
- K092211
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- K2m, Inc.
- Date Received
- July 22, 2009
- Decision Date
- March 5, 2010
- Product Code
- OVD
- 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 |
|---|---|---|---|
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | FDA class 2 | Orthopedic |
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