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Scient'x Tribeca Vbr

by Scien'Tx USA, Inc.

510(k) K080588

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK080588 Date30 May 2008ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
MAX
FDA applicant
Scient'X USA, Inc.
Device Class
Class II
Regulation
21 CFR Part 888.3080
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Scient'x Tribeca Vbr is an intervertebral fusion device with bone graft, lumbar, classified under product code MAX. It is indicated for use with autogenous bone graft as an intervertebral body fusion device at either one or two contiguous lumbar levels.

The device received FDA 510(k) clearance (K080588) on May 30, 2008, following a traditional review process. It is supplied non-sterile and intended for single-use implantation in orthopedic spinal fusion procedures. Storage and handling should follow manufacturer guidelines for implantable devices.

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Questions

AI-generated answers, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Scient'x Tribeca Vbr used for?

    The Scient'x Tribeca Vbr is indicated for use as an intervertebral body fusion device with autogenous bone graft at either one or two contiguous lumbar levels in spinal fusion procedures.

  • Is the Scient'x Tribeca Vbr sterile when supplied?

    The device is supplied non-sterile and must be sterilized by the user prior to implantation, following the manufacturer's recommended sterilization procedures for implantable devices.

  • Can the Scient'x Tribeca Vbr be reused after implantation?

    The Scient'x Tribeca Vbr is intended for single-use only and should not be reused, as reusing the device may compromise its structural integrity and increase the risk of infection or failure.