FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EL CAPITAN Anterior Lumber Interbody System
K Number: K192492
·
Decision Apr 21, 2020
Classifications
1
FEI Numbers
253
Registration Numbers
253
Same Product Code
200
Applicant Total
8
Review Days
223
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Basic Information
- Device Name
- EL CAPITAN Anterior Lumber Interbody System
- K Number
- K192492
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Astura Medical, LLC
- Date Received
- September 11, 2019
- Decision Date
- April 21, 2020
- Product Code
- OVD
- 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 |
|---|---|---|---|
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | FDA class 2 | Orthopedic |
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Other Clearances by Astura Medical, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K202495 | SIRION Lateral Lumbar Interbody Fusion | Jan 6, 2021 | Substantially Equivalent |
| K202065 | DOLOMITE Anterior Cervical Stabilization System | Oct 26, 2020 | Substantially Equivalent |
| K192006 | SIRION Lateral Lumbar Interbody System | Apr 2, 2020 | Substantially Equivalent |
| K190426 | ALTA Anterior Cervical Corpectomy System | Oct 24, 2019 | Substantially Equivalent |
| K182877 | HALF DOME Posterior Lumbar Interbody System | May 3, 2019 | Substantially Equivalent |
| K182239 | OLYMPIC Posterior Spinal Fixation System | Oct 18, 2018 | Substantially Equivalent |
| K181139 | OLYMPIC Posterior Spinal Fixation System | Jul 6, 2018 | Substantially Equivalent |