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Streamline Navigated Instruments

by Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)

510(k) K200095

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

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 NumberK200095 Date26 Jun 2020ClearedStatusActive

Recalls

4 recalls · 1 ongoing · FDA

    • Ongoing Z-0322-2021 FDA Class II initiated 24 Sep 2020

    System does not include a drill guide.

  • 2 recalls, same reason

    • Terminated Z-0300-2021 FDA Class II initiated 24 Sep 2020
    • Terminated Z-0299-2021 FDA Class II initiated 24 Sep 2020

    The Streamline Navigation System taps have experienced binding with other devices.

    • Terminated Z-0320-2021 FDA Class II initiated 11 Sep 2020

    The Streamline MIS Navigation System taps are not compatible with the Streamline MIS tap sleeve.

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  • Withdrawn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
OLO
FDA applicant
Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.
Device class
Class II
Regulation
21 CFR Part 882.4560
Advisory committee
Neurology
FDA decision
SESE Substantially Equivalent

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