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ATLAS SPINE INC.

Last updated September 17, 2026

Information

Page 19 of 19

Device	Model / Reference	Registries	Class	Status
Apclo Pedicle Screw Systems	K112759	FDA 510(k)	Class II	Active
Ortus™ Expandable Lumbar Interbody Fusion System	K172334	FDA 510(k)	Class II	Active
Atlas Spine Vertebral Body Replacement	K063464	FDA 510(k)	Class II	Active
Atlas Spine HiRISE™ Expandable Cervical Corpectomy System	K252560	FDA 510(k)	Class II	Active
Atlas Spine Rebar (Ti) Spacer System	K202302	FDA 510(k)	Class II	Active
Atlas Spine Expandable Cervical Interbody System	K180675	FDA 510(k)	Class II	Active
Atlas Spine Spacer	K091406	FDA 510(k)	Class II	Active
V3 Segmental Plating System	K182418	FDA 510(k)	Class II	Active
Atlas Spine Vertebral Body Replacement	K063205	FDA 510(k)	Class II	Active
Atlas Spine Pivoting System	K100743	FDA 510(k)	Class II	Active

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Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Jul 26, 2013	Z-1616-2016	—	terminated	The device was not appropriately set to mitigate the risk of implant fracture upon rotation inside the disc space.
Jun 4, 2009	Z-2274-2012	—	terminated	Atlas Spine, Inc. recalled their Apelo Modular Screwdriver, a component of the Apelo Pedicle Screw System Instrumentation, because of complaints received about the tip breaking. If the tip is fractured inside of the modular screw, the tip could become implanted in the body or if the entire screw is removed, it could cause a delay in the surgery.