FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Spinal Inner Fixation System
K Number: K143013
·
Decision Dec 11, 2015
Classifications
1
FEI Numbers
326
Registration Numbers
326
Same Product Code
308
Applicant Total
2
Review Days
417
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Basic Information
- Device Name
- Spinal Inner Fixation System
- K Number
- K143013
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3070
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Changzhou Dingjian Medical Appliance Co., Ltd.
- Date Received
- October 20, 2014
- Decision Date
- December 11, 2015
- Product Code
- MNH
- 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 |
|---|---|---|---|
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | FDA class 2 | Orthopedic |
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Other Clearances by Changzhou Dingjian Medical Appliance Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K143002 | Metallic Locking Bone Plate and Screw System | Jun 5, 2015 | Substantially Equivalent |