FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NuVasive® VersaTie System
K Number: K173117
·
Decision Dec 7, 2017
Classifications
1
FEI Numbers
65
Registration Numbers
65
Same Product Code
36
Applicant Total
91
Review Days
69
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Basic Information
- Device Name
- NuVasive® VersaTie System
- K Number
- K173117
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3010
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nuvasive, Inc.
- Date Received
- September 29, 2017
- Decision Date
- December 7, 2017
- Product Code
- OWI
- 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 |
|---|---|---|---|
| OWI | Bone Fixation Cerclage, Sublaminar | FDA class 2 | Orthopedic |
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