Submission Details
| 510(k) Number | K210542 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 24, 2021 |
| Decision Date | June 30, 2021 |
| Days to Decision | 126 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
Cleared
Traditional
aprevo Transforaminal IBF
Jun 2021
Decision
126d
Days
Class 2
Risk
About This 510(k) Submission
K210542 is an FDA 510(k) clearance for the aprevo Transforaminal IBF, a Intervertebral Fusion Device With Bone Graft, Lumbar (Class II — Special Controls, product code MAX), submitted by Carlsmed, Inc. (La Jolla, US). The FDA issued a Cleared decision on June 30, 2021, 126 days after receiving the submission on February 24, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.
Device Classification
| Product Code | MAX — Intervertebral Fusion Device With Bone Graft, Lumbar |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 888.3080 |
| Definition | Intended To Stabilize Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft. |
Manufacturer
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