FDA 510(k)

Atlas Spine Project X Expandable Posterior Lumbar Interbody System

K-Nummer: K251969 · 2025-08-15

Entscheidungsdatum2025-08-15

ProduktcodeMAX

BeratungsausschussOR

EntscheidungSubstantially Equivalent

Produktübersicht

Atlas Spine Project X Expandable Posterior Lumbar Interbody System is the device name listed in this FDA 510(k) record. The listed applicant is Atlas Spine, Inc.. It received FDA 510(k) clearance on 2025-08-15 under 510(k) number K251969. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the Atlas Spine Project X Expandable Posterior Lumbar Interbody System?

Atlas Spine Project X Expandable Posterior Lumbar Interbody System is a medical device that received FDA 510(k) clearance on 2025-08-15. The listed applicant is Atlas Spine, Inc.. The 510(k) number is K251969.

When did Atlas Spine Project X Expandable Posterior Lumbar Interbody System receive FDA 510(k) clearance?

Atlas Spine Project X Expandable Posterior Lumbar Interbody System received FDA 510(k) clearance on 2025-08-15, under 510(k) number K251969.

Who is the listed applicant for Atlas Spine Project X Expandable Posterior Lumbar Interbody System?

The FDA 510(k) record lists Atlas Spine, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Atlas Spine Project X Expandable Posterior Lumbar Interbody System?

The FDA product code for Atlas Spine Project X Expandable Posterior Lumbar Interbody System is MAX.

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Weitere Einträge mit Atlas Spine, Inc. als Antragsteller

K252822Atlas Spine HiRISE™ Expandable Cervical-p Corpectomy Implant K252560Atlas Spine HiRISE™ Expandable Cervical Corpectomy System K243191Atlas Spine Lateral Expandable Interbody System K202302Atlas Spine Rebar (Ti) Spacer System K192570Atlas Spine Expandable Cervical Standalone Interbody System K182418V3 Segmental Plating System

Alle 10 Geräte anzeigen →

Verwandte Geräte (Code: MAX)

K261049SCALA® TLSpineart SA K261430TruLift Expandable SystemLife Spine, Inc.K253011Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian Anterior Plate System; Reef L Interbody System; Reef TO/TA System; Regatta Lateral System; Regatta Lateral Plate System; Shoreline ACS Interbody System; Shoreline Threaded TruProfile Plate; Shoreline RT Interbody System; Vu Mesh; WaveForm A Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TA Interbody System; WaveForm TO Interbody SystemSeaSpine Orthopedics Corporation K253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.

Offizielle Quelle

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