FDA 510(k)
FDA class 2
Substantially Equivalent
🇧🇷 Brazil
Pedimax II - Pedicular Screw Spinal System
K Number: K180626
·
Decision Feb 1, 2019
Classifications
1
FEI Numbers
407
Registration Numbers
407
Same Product Code
900
Applicant Total
3
Review Days
329
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Basic Information
- Device Name
- Pedimax II - Pedicular Screw Spinal System
- K Number
- K180626
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3070
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Gm Dos Reis Industria E Comerico Ltda.
- Date Received
- March 9, 2018
- Decision Date
- February 1, 2019
- Product Code
- NKB
- 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 |
|---|---|---|---|
| NKB | Thoracolumbosacral Pedicle Screw System | FDA class 2 | Orthopedic |
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