FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAM
K Number: K242260
·
Decision Nov 15, 2024
Classifications
1
FEI Numbers
339
Registration Numbers
339
Same Product Code
348
Applicant Total
21
Review Days
107
Basic Information
- Device Name
- aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAM
- K Number
- K242260
- 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 31, 2024
- Decision Date
- November 15, 2024
- 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 Carlsmed, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K260385 | aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and transforaminal lumbar interbody system; aprevo® cervical interbody system; corra cervical plating system | May 9, 2026 | Substantially Equivalent |
| K260570 | corra cervical plating system | Apr 22, 2026 | Substantially Equivalent |
| K252894 | aprevo® cervical interbody system | Jan 6, 2026 | Substantially Equivalent |
| K252611 | aprevo® cervical plating system | Dec 22, 2025 | Substantially Equivalent |
| 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 |
| K250987 | aprevo® posterior/transforaminal lumbar interbody fusion device | Jun 30, 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 |