FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TECTONIC CERVICAL PLATE SYSTEM
K Number: K051531
·
Decision Oct 17, 2005
Classifications
1
FEI Numbers
356
Registration Numbers
356
Same Product Code
665
Applicant Total
8
Review Days
130
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Basic Information
- Device Name
- TECTONIC CERVICAL PLATE SYSTEM
- K Number
- K051531
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3060
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- K2m, LLC
- Date Received
- June 9, 2005
- Decision Date
- October 17, 2005
- 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 |
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|---|---|---|---|
| K180665 | SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage System | Nov 28, 2018 | Substantially Equivalent |
| K140529 | EVEREST SPINAL SYSTEM | May 22, 2014 | Substantially Equivalent |
| K052404 | DENALI DEFORMITY SYSTEM | May 23, 2006 | Substantially Equivalent |
| K060442 | PYRENEES CERVICAL PLATE SYSTEM | May 15, 2006 | Substantially Equivalent |
| K052398 | MESA SPINAL SYSTEM | Dec 7, 2005 | Substantially Equivalent |
| K051454 | ALEUTIAN SPACER SYSTEM | Jul 27, 2005 | Substantially Equivalent |
| K042635 | DENALI SPINE SYSTEM | Jan 10, 2005 | Substantially Equivalent |