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FDA 510(k)

SPIRA Open Matrix ALIF and LLIF

K-Number: K190483 · 2019-09-23

ApplicantCamber Spine Technologies
Decision Date2019-09-23
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SPIRA Open Matrix ALIF and LLIF is the device name listed in this FDA 510(k) record. The listed applicant is Camber Spine Technologies. It received FDA 510(k) clearance on 2019-09-23 under 510(k) number K190483. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPIRA Open Matrix ALIF and LLIF?

SPIRA Open Matrix ALIF and LLIF is a medical device that received FDA 510(k) clearance on 2019-09-23. The listed applicant is Camber Spine Technologies. The 510(k) number is K190483.

When did SPIRA Open Matrix ALIF and LLIF receive FDA 510(k) clearance?

SPIRA Open Matrix ALIF and LLIF received FDA 510(k) clearance on 2019-09-23, under 510(k) number K190483.

Who is the listed applicant for SPIRA Open Matrix ALIF and LLIF?

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

What is the FDA product code for SPIRA Open Matrix ALIF and LLIF?

The FDA product code for SPIRA Open Matrix ALIF and LLIF is MAX.

Other records listing Camber Spine Technologies as applicant

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Related Devices (Code: MAX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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 SySeaSpine Orthopedics CorporationK253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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