FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Posterior Cervical Spine System
K Number: K233078
·
Decision Nov 22, 2023
Classifications
1
FEI Numbers
164
Registration Numbers
164
Same Product Code
117
Applicant Total
12
Review Days
58
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Basic Information
- Device Name
- Posterior Cervical Spine System
- K Number
- K233078
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3075
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Double Medical Technology, Inc.
- Date Received
- September 25, 2023
- Decision Date
- November 22, 2023
- Product Code
- NKG
- 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 |
|---|---|---|---|
| NKG | Posterior Cervical Screw System | FDA class 2 | Orthopedic |
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Other Clearances by Double Medical Technology, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K252729 | Universal Spinal System | Nov 18, 2025 | Substantially Equivalent |
| K242348 | Locking Screw,CoCrMo | Dec 4, 2024 | Substantially Equivalent |
| K223753 | Cervical Plate System | Mar 14, 2023 | Substantially Equivalent |
| K221150 | Advanced Bone Plate | Jan 25, 2023 | Substantially Equivalent |
| K221088 | Anatomic Bone Plate | Jan 18, 2023 | Substantially Equivalent |
| K221090 | Metal Cannulated Screw | Jan 10, 2023 | Substantially Equivalent |
| K221221 | Advanced Intramedullary Nail System | Dec 21, 2022 | Substantially Equivalent |
| K220921 | Metal Bone Screw | Dec 12, 2022 | Substantially Equivalent |
| K172830 | Double Medical Femoral Nail System | Aug 24, 2018 | Substantially Equivalent |
| K172828 | Double Medical Cage System | Feb 1, 2018 | Substantially Equivalent |