510(k) K241477
- Device
- aprevo® anterior lumbar interbody fusion device with interfixation
- Applicant
- Carlsmed, Inc.
- 510(k) number
- K241477
- Product code
- OVD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-10-09
- Date received
- 2024-05-24
- Regulation
- 888.3080
- Classification name
- Intervertebral Fusion Device With Integrated Fixation, Lumbar
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Karen Liu
- Address
- 1800 Aston Ave. Suite 100 Carlsbad CA US 92008 92008
FDA Registration Numbers
- 1423662
- 1450662
- 1000200989
- 3014967969
- 2133928
- 3005180920
- 3012131184
- 3013820501
- 3009241418
- 2530808
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Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
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