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9733450

by Medtronic Navigation Inc. 3 variants

9733450 is a Class II device made by Medtronic Navigation Inc., cleared under FDA 510(k) K153555 on 7 Apr 2016 and listed in FDA GUDID since 25 Oct 2018 (UDI-DI 00763000053390), active as of 8 Nov 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

8 closed

Documents

510(k) K153555

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00763000053390 UDI-DI Date25 Oct 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK153555 Date7 Apr 2016DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K153555 decided 7 Apr 2016 Active
  • FDA GUDID UDI-DI 00763000053390 listed 25 Oct 2018 Listed

Recalls

8 recalls · FDA

  • 8 recalls, same reason

    • Terminated Z-3053-2017 FDA Class II initiated 29 Jun 2017 on shared 510(k) K153555
    • Terminated Z-3054-2017 FDA Class II initiated 29 Jun 2017 on shared 510(k) K153555
    • Terminated Z-3055-2017 FDA Class II initiated 29 Jun 2017 on shared 510(k) K153555
    • Terminated Z-3056-2017 FDA Class II initiated 29 Jun 2017 on shared 510(k) K153555
    • Terminated Z-3052-2017 FDA Class II initiated 29 Jun 2017 on shared 510(k) K153555
    • Terminated Z-3051-2017 FDA Class II initiated 29 Jun 2017 on shared 510(k) K153555
    • Terminated Z-3057-2017 FDA Class II initiated 29 Jun 2017 on shared 510(k) K153555
    • Terminated Z-3058-2017 FDA Class II initiated 29 Jun 2017 on shared 510(k) K153555

    The instruments are not able to pass instrument verification which is performed prior to the use of each instrument.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

10 dated events

  1. Cleared FDA 510(k) K153555
  2. Recall initiated FDA recalls Z-3053-2017
  3. Recall initiated FDA recalls Z-3054-2017
  4. Recall initiated FDA recalls Z-3055-2017
  5. Recall initiated FDA recalls Z-3056-2017
  6. Recall initiated FDA recalls Z-3052-2017
  7. Recall initiated FDA recalls Z-3051-2017
  8. Recall initiated FDA recalls Z-3057-2017
  9. Recall initiated FDA recalls Z-3058-2017
  10. Listed FDA GUDID 00763000053390

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Multi-purpose stereotactic surgery system
Model / reference
9733450
Primary DI / UDI-DI
00763000053390
510(k) Number
FDA product code
HAW
GMDN term
Multi-purpose stereotactic surgery system
Device class
Class II
Regulation number
882.4560
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Multi-purpose stereotactic surgery system

Cleared under the same submission (K153555)

and 8 more cleared under K153555

Similar devices in this category

Other devices filed under Multi-purpose stereotactic surgery system.

Other devices from Medtronic Navigation Inc.

See all devices from Medtronic Navigation Inc. →

Properties

  • Sterilise before use
  • Single use
  • Prescription use
  • Lot / batch number
Other properties (11, all answered No)