FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KASILOF Cervical Plate System
K Number: K203154
·
Decision Nov 5, 2020
Classifications
1
FEI Numbers
356
Registration Numbers
356
Same Product Code
665
Applicant Total
2
Review Days
14
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Basic Information
- Device Name
- KASILOF Cervical Plate System
- K Number
- K203154
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3060
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Kahtnu Surgical, Inc.
- Date Received
- October 22, 2020
- Decision Date
- November 5, 2020
- Product Code
- KWQ
- 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 |
|---|---|---|---|
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KWQ), ordered by most recent decision date.
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Other Clearances by Kahtnu Surgical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K213115 | CHENA-C Spacer System | Dec 6, 2021 | Substantially Equivalent |