FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Reform Pedicle Screw System
K Number: K200303
·
Decision May 19, 2020
Classifications
1
FEI Numbers
407
Registration Numbers
407
Same Product Code
900
Applicant Total
2
Review Days
103
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Basic Information
- Device Name
- Reform Pedicle Screw System
- K Number
- K200303
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3070
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Precision Spine
- Date Received
- February 6, 2020
- Decision Date
- May 19, 2020
- 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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Other Clearances by Precision Spine
| K Number | Device Name | ||
|---|---|---|---|
| K192494 | NexGen Anterior Cervical Plate System | Oct 29, 2019 | Substantially Equivalent |