FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DIAMONDBACK SPINAL SYSTEM
K Number: K100377
·
Decision Apr 22, 2010
Classifications
1
FEI Numbers
342
Registration Numbers
342
Same Product Code
302
Applicant Total
11
Review Days
69
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Basic Information
- Device Name
- DIAMONDBACK SPINAL SYSTEM
- K Number
- K100377
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3070
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Eminent Spine
- Date Received
- February 12, 2010
- Decision Date
- April 22, 2010
- 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 |
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|---|---|---|---|
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| K242069 | Eminent Spine Scoliosis Deformity Pedicle Screw System | Sep 3, 2024 | Substantially Equivalent |
| K212701 | Eminent Spine 3D Cervical Interbody Fusion System | Feb 6, 2023 | Substantially Equivalent |
| K221936 | Standalone ALIF Interbody Fusion System | Oct 17, 2022 | Substantially Equivalent |
| K143365 | Eminent Foot Plate System | Mar 30, 2015 | Substantially Equivalent |
| K133194 | DIAMOND RATTLESNAKE SYSTEM | Jun 26, 2014 | Substantially Equivalent |
| K103068 | KING COBRA ANTERIOR CERVICAL PLATE | Jan 14, 2011 | Substantially Equivalent |
| K090415 | EMINENT SPINE BUTTRESS (FANG) PLATE SYSTEM | Jun 1, 2009 | Substantially Equivalent |
| K090064 | EMINENT SPINE INTERBODY FUSION SYSTEM | Apr 9, 2009 | Substantially Equivalent |