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FDA 510(k)

UniSpace® Stand-Alone C Cage

K-Number: K234119 · 2024-04-19

ApplicantInnosys Co., Ltd.
Decision Date2024-04-19
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

UniSpace® Stand-Alone C Cage is the device name listed in this FDA 510(k) record. The listed applicant is Innosys Co., Ltd.. It received FDA 510(k) clearance on 2024-04-19 under 510(k) number K234119. The device is classified under product code OVE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UniSpace® Stand-Alone C Cage?

UniSpace® Stand-Alone C Cage is a medical device that received FDA 510(k) clearance on 2024-04-19. The listed applicant is Innosys Co., Ltd.. The 510(k) number is K234119.

When did UniSpace® Stand-Alone C Cage receive FDA 510(k) clearance?

UniSpace® Stand-Alone C Cage received FDA 510(k) clearance on 2024-04-19, under 510(k) number K234119.

Who is the listed applicant for UniSpace® Stand-Alone C Cage?

The FDA 510(k) record lists Innosys Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UniSpace® Stand-Alone C Cage?

The FDA product code for UniSpace® Stand-Alone C Cage is OVE.

Related Clinical Trials

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.

NCT05762055Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative TechnologyENROLLING_BY_INVITATION

Other records listing Innosys Co., Ltd. as applicant

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.

K241082INNOVERSE Navigation InstrumentsK233960INNOVERSE Spinal SystemK231737ANAX™ 5.5 Spinal SystemK221084Dyna Locking Trochanteric Nail™

Related Devices (Code: OVE)

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.

K261451ZSAlign Cervical Interbody SystemZSFab, Inc.K262094E3D™-C Interbody SystemEvolution SpineK261279DeltaNEC Interbody SystemNexus SpineK252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.K260660SABER-C SystemElevation Spine

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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