FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
aprevo® anterior lumbar interbody fusion device with interfixation
K Number: K222009
·
Decision Nov 22, 2022
Classifications
1
FEI Numbers
254
Registration Numbers
254
Same Product Code
194
Applicant Total
14
Review Days
138
Basic Information
- Device Name
- aprevo® anterior lumbar interbody fusion device with interfixation
- K Number
- K222009
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Carlsmed, Inc.
- Date Received
- July 7, 2022
- Decision Date
- November 22, 2022
- 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 Carlsmed, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K250827 | aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion device; aprevo® anterior lumbar interbody fusion device with interfixation; aprevo® transforaminal lumbar interbody fusion device; aprevo® TLIF-CA Articulating System; aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X No Cams | Jul 7, 2025 | Substantially Equivalent |
| K243802 | aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar interbody fusion device with interfixation | Mar 17, 2025 | Substantially Equivalent |
| K242599 | aprevo® Digital Planning | Dec 20, 2024 | Substantially Equivalent |
| K243635 | aprevo® anterior lumbar interbody fusion device with interfixation | Dec 13, 2024 | Substantially Equivalent |
| K241477 | aprevo® anterior lumbar interbody fusion device with interfixation | Oct 9, 2024 | Substantially Equivalent |
| K241332 | aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar interbody fusion devices with interfixation; aprevo® transforaminal lumbar interbody fusion device | Sep 20, 2024 | Substantially Equivalent |
| K232282 | aprevo® anterior and lateral lumbar interbody fusion device, aprevo® transforaminal lumbar interbody fusion device | Mar 22, 2024 | Substantially Equivalent |
| K231955 | aprevo® Digital Segmentation | Nov 3, 2023 | Substantially Equivalent |
| K231140 | aprevo® transforaminal lumbar interbody fusion device | May 19, 2023 | Substantially Equivalent |
| K222195 | aprevo® Digital Workflow | Dec 30, 2022 | Substantially Equivalent |