FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Cavetto [MAX] Cervical Cage System
K Number: K201769
·
Decision Sep 3, 2020
Classifications
1
FEI Numbers
339
Registration Numbers
339
Same Product Code
348
Applicant Total
15
Review Days
66
Basic Information
- Device Name
- Cavetto [MAX] Cervical Cage System
- K Number
- K201769
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Neurostructures, Inc.
- Date Received
- June 29, 2020
- Decision Date
- September 3, 2020
- Product Code
- ODP
- 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 |
|---|---|---|---|
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | FDA class 2 | Orthopedic |
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Other Clearances by Neurostructures, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K200115 | Cavetto-SA Cervical Cage System | Sep 24, 2020 | Substantially Equivalent |
| K200927 | Transept Cervical Plate System | Jul 24, 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 |