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FDA 510(k)

TRANS1 INTERBODY FUSION SYSTEM

K-Number: K120991 · 2012-08-23

ApplicantTrans1 Incorporated
Decision Date2012-08-23
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TRANS1 INTERBODY FUSION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Trans1 Incorporated. It received FDA 510(k) clearance on 2012-08-23 under 510(k) number K120991. 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 TRANS1 INTERBODY FUSION SYSTEM?

TRANS1 INTERBODY FUSION SYSTEM is a medical device that received FDA 510(k) clearance on 2012-08-23. The listed applicant is Trans1 Incorporated. The 510(k) number is K120991.

When did TRANS1 INTERBODY FUSION SYSTEM receive FDA 510(k) clearance?

TRANS1 INTERBODY FUSION SYSTEM received FDA 510(k) clearance on 2012-08-23, under 510(k) number K120991.

Who is the listed applicant for TRANS1 INTERBODY FUSION SYSTEM?

The FDA 510(k) record lists Trans1 Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRANS1 INTERBODY FUSION SYSTEM?

The FDA product code for TRANS1 INTERBODY FUSION SYSTEM is MAX.

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Other records listing Trans1 Incorporated 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.

K102334TRANS1 AXIALIF PLUSK100210TRANS1 LATERAL INTERVERTEBRAL FUSION DEVICE, TK092124AXIALIF 2L, AXIALIF 2-LEVEL SYSTEM, AXIALIF APOLLO, AXIALIF IIK073643TRANS1 AXIALIF 2-LEVEL OR II SYSTEMK073515TRANS1 FACET SCREWK073514TRANS1 AXIAL FIXATON SYSTEM

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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.

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

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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