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Navigated Infinity ™ Instruments 3607037

by Medtronic Sofamor Danek, Inc.

Navigated Infinity ™ Instruments 3607037 is a Class II device made by Medtronic Sofamor Danek, Inc., cleared under FDA 510(k) K173338 on 18 Jan 2018 and listed in FDA GUDID since 1 Sep 2018 (UDI-DI 00643169839663), active as of 22 Oct 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 found

in data synced 22 Oct 2026

Documents

510(k) K173338

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00643169839663 UDI-DI Date1 Sep 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK173338 Date18 Jan 2018DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K173338 decided 18 Jan 2018 Active
  • FDA GUDID UDI-DI 00643169839663 listed 1 Sep 2018 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K173338
  2. Listed FDA GUDID 00643169839663

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Navigated Infinity ™ Instruments
Generic name
Instrument tray, reusable
Model / reference
3607037
Primary DI / UDI-DI
00643169839663
510(k) Number
FDA product code
OLO
GMDN term
Instrument tray, reusable
Device class
Class II
Regulation number
882.4560
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Instrument tray, reusable

Cleared under the same submission (K173338)

and 5 more cleared under K173338

Similar devices in this category

Other devices filed under Instrument tray, reusable.

Other devices from Medtronic Sofamor Danek, Inc.

See all devices from Medtronic Sofamor Danek, Inc. →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
Other properties (12, all answered No)