FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Double Medical Universal Spine System
K Number: K151458
·
Decision Aug 22, 2016
Classifications
1
FEI Numbers
342
Registration Numbers
342
Same Product Code
302
Applicant Total
12
Review Days
448
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Double Medical Universal Spine System
- K Number
- K151458
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3070
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Double Medical Technology, Inc.
- Date Received
- June 1, 2015
- Decision Date
- August 22, 2016
- Product Code
- MNI
- 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 |
|---|---|---|---|
| MNI | Orthosis, Spinal Pedicle Fixation | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MNI), ordered by most recent decision date.
Mikron Spinal Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
LumFix Spinal Fixation Sytem
FDA 510(k)
FDA Class 2
·Orthopedic
MySpine Pedicle Screw Placement Guides - LP
FDA 510(k)
FDA Class 2
·Orthopedic
LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
Premier
FDA 510(k)
FDA Class 2
·Orthopedic
Sniper (R) Spine System
FDA 510(k)
FDA Class 2
·Orthopedic
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 |
| K233078 | Posterior Cervical Spine System | Nov 22, 2023 | 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 |