510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K202065Substantially Equivalent

DOLOMITE Anterior Cervical Stabilization System

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

K202065 is the FDA 510(k) clearance record for DOLOMITE Anterior Cervical Stabilization System, a class II device, cleared for Astura Medical, LLC on under FDA product code OVE (Intervertebral Fusion Device With Integrated Fixation, Cervical). FDA's definition for product code OVE reads: "Intended to stabilize cervical 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 K202065.

Clearance record

Decision date
Received
(91 days to decision)
Product code
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
Regulation
21 CFR 888.3080
Device class
Class II
Review panel
Orthopedic
Applicant
Astura Medical, LLC 4949 W. Royal Ln., Irving TX
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OVE

Trailing 12 months
13 clearances under product code OVE in the twelve months to October 2026, April 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code OVE, trailing twelve months
MonthClearances
November 20250
December 20252
January 20260
February 20261
March 20260
April 20263
May 20260
June 20263
July 20262
August 20261
September 20261
October 20260