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510(k) K231140

aprevo® transforaminal lumbar interbody fusion device by Carlsmed, Inc. — Product Code MAX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 19, 2023
Date Received
April 21, 2023
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Intervertebral Fusion Device With Bone Graft, Lumbar
Device Class
Class II
Regulation Number
888.3080
Review Panel
OR
Submission Type

Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.

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  • K241477 — aprevo® anterior lumbar interbody fusion device with interfixation (October 9, 2024)
  • K241332 — aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lu (September 20, 2024)

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