FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IMPLANET SPINE SYSTEM
K Number: K132303
·
Decision Oct 10, 2013
Classifications
1
FEI Numbers
158
Registration Numbers
158
Same Product Code
18
Applicant Total
15
Review Days
78
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Basic Information
- Device Name
- IMPLANET SPINE SYSTEM
- K Number
- K132303
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3070
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Implanet, S.A.
- Date Received
- July 24, 2013
- Decision Date
- October 10, 2013
- Product Code
- OSH
- 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 |
|---|---|---|---|
| OSH | Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | FDA class 2 | Orthopedic |
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