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FDA 510(k)

SCIENT'X TRIBECA VBR

K-Number: K080588 · 2008-05-30

ApplicantScient'X USA, Inc.
Decision Date2008-05-30
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SCIENT'X TRIBECA VBR is the device name listed in this FDA 510(k) record. The listed applicant is Scient'X USA, Inc.. It received FDA 510(k) clearance on 2008-05-30 under 510(k) number K080588. 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 SCIENT'X TRIBECA VBR?

SCIENT'X TRIBECA VBR is a medical device that received FDA 510(k) clearance on 2008-05-30. The listed applicant is Scient'X USA, Inc.. The 510(k) number is K080588.

When did SCIENT'X TRIBECA VBR receive FDA 510(k) clearance?

SCIENT'X TRIBECA VBR received FDA 510(k) clearance on 2008-05-30, under 510(k) number K080588.

Who is the listed applicant for SCIENT'X TRIBECA VBR?

The FDA 510(k) record lists Scient'X USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SCIENT'X TRIBECA VBR?

The FDA product code for SCIENT'X TRIBECA VBR is MAX.

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Other records listing Scient'X USA, Inc. 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.

K081548ANTERIOR BUTTRESS PLATEK053292DAVANTIS/ANTELYS VERTEBRAL BODY REPLACEMENTSK031290MODIFICATION TO EASYS TRANSVERSE CONNECTION

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.

K261049SCALA® TLSpineart SAK261430TruLift 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.

Official Source

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

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