FDA 510(k)

X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage System

K-Nummer: K251617 · 2025-06-16

AntragstellerExpanding Innovations, Inc.

Entscheidungsdatum2025-06-16

ProduktcodeMAX

BeratungsausschussOR

EntscheidungSubstantially Equivalent

Produktübersicht

X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage System is the device name listed in this FDA 510(k) record. The listed applicant is Expanding Innovations, Inc.. It received FDA 510(k) clearance on 2025-06-16 under 510(k) number K251617. 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 X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage System?

X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage System is a medical device that received FDA 510(k) clearance on 2025-06-16. The listed applicant is Expanding Innovations, Inc.. The 510(k) number is K251617.

When did X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage System receive FDA 510(k) clearance?

X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage System received FDA 510(k) clearance on 2025-06-16, under 510(k) number K251617.

Who is the listed applicant for X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage System?

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

What is the FDA product code for X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage System?

The FDA product code for X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage System is MAX.

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Weitere Einträge mit Expanding Innovations, Inc. als Antragsteller

K251003X-PAC® LLIF Expandable Lateral Cage System K250602X-PAC® N-GAGE™ Lumbar Plate System K223174X-Pac Expandable LLIF Cage System K222797X-Pac Expandable Lumbar Cage System K220655X-Pac Expandable Lumbar Cage System K203802X-Pac Expandable Lumbar Cage System

Alle 8 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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