510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K210035Substantially Equivalent

ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix Anterior Cervical Plate System, Spinema Lumbar Plate System

Aegis Spine, Inc., Englewood CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K210035 is the FDA 510(k) clearance record for ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix Anterior Cervical Plate System, Spinema Lumbar Plate System, a class II device, cleared for Aegis Spine on under FDA product code OUR (Sacroiliac Joint Fixation). FDA's definition for product code OUR reads: "sacroiliac joint fusion". FDA records list 6 510(k) clearances for Aegis Spine, from to . As of , FDA records show no recalls naming K210035.

Clearance record

Decision date
Received
(41 days to decision)
Product code
OUR Sacroiliac Joint Fixation
Regulation
21 CFR 888.3040
Device class
Class II
Review panel
Orthopedic
Applicant
Aegis Spine 9781 S. Meridian Blvd., Suite 300, Englewood CO
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OUR

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