FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NUVASIVE COROENT SYSTEM
K Number: K081611
·
Decision Oct 2, 2008
Classifications
1
FEI Numbers
339
Registration Numbers
339
Same Product Code
348
Applicant Total
91
Review Days
115
Basic Information
- Device Name
- NUVASIVE COROENT SYSTEM
- K Number
- K081611
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nuvasive, Inc.
- Date Received
- June 9, 2008
- Decision Date
- October 2, 2008
- Product Code
- ODP
- 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 |
|---|---|---|---|
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | FDA class 2 | Orthopedic |
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