FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Transept Cervical Plate System
K Number: K200927
·
Decision Jul 24, 2020
Classifications
1
FEI Numbers
356
Registration Numbers
356
Same Product Code
665
Applicant Total
15
Review Days
108
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Basic Information
- Device Name
- Transept Cervical Plate System
- K Number
- K200927
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3060
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Neurostructures, Inc.
- Date Received
- April 7, 2020
- Decision Date
- July 24, 2020
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KWQ), ordered by most recent decision date.
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Other Clearances by Neurostructures, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K200115 | Cavetto-SA Cervical Cage System | Sep 24, 2020 | Substantially Equivalent |
| K201769 | Cavetto [MAX] Cervical Cage System | Sep 3, 2020 | Substantially Equivalent |
| K192248 | Cortina [MAX] Lumbar Cage System | Nov 25, 2019 | Substantially Equivalent |
| K182195 | Arco-SA Lumbar Cage System | Nov 9, 2018 | Substantially Equivalent |
| K181590 | Neurostructures Cavetto® [MAX] Cervical Cage System | Nov 8, 2018 | Substantially Equivalent |
| K173082 | Arco-SA Lumbar Cage System | Mar 29, 2018 | Substantially Equivalent |
| K180431 | Cortina [MAX] Lumbar Cage System | Mar 22, 2018 | Substantially Equivalent |
| K172320 | Neurostructures Cavetto® Cervical Cage System | Feb 26, 2018 | Substantially Equivalent |
| K173077 | Cavetto-SA Cervical Cage System | Feb 23, 2018 | Substantially Equivalent |
| K171914 | Cortina Lumbar Cage System | Oct 25, 2017 | Substantially Equivalent |