510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K192492Substantially Equivalent

EL CAPITAN Anterior Lumber Interbody System

Astura Medical, Carlsbad CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K192492 is the FDA 510(k) clearance record for EL CAPITAN Anterior Lumber Interbody System, a class II device, cleared for Astura Medical, LLC on under FDA product code OVD (Intervertebral Fusion Device With Integrated Fixation, Lumbar). FDA's definition for product code OVD reads: "Intended to stabilize lumbar spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation". FDA records list 29 510(k) clearances for Astura Medical, LLC, from to . As of , FDA records show no recalls naming K192492.

Clearance record

Decision date
Received
(223 days to decision)
Product code
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Regulation
21 CFR 888.3080
Device class
Class II
Review panel
Orthopedic
Applicant
Astura Medical, LLC 3186 Lionshead Ave. Suite 100, Carlsbad CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OVD

Trailing 12 months
9 clearances under product code OVD in the twelve months to October 2026, July 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code OVD, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20261
March 20260
April 20261
May 20261
June 20261
July 20262
August 20261
September 20261
October 20260