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Assure 110.028

by Globus Medical, Inc.

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) K050391

FDA submission, from GUDID

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00889095035070 UDI-DI Date7 Nov 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK050391 Date21 Jul 2005DecidedStatusActive

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  • Withdrawn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

GUDID

Trade name
Assure
Generic name
Spinal fixation plate, non-bioabsorbable
Model / reference
110.028
Primary DI / UDI-DI
00889095035070
510(k) Number
FDA product code
KWQ
GMDN term
Spinal fixation plate, non-bioabsorbable
Device class
Class II
Regulation number
888.3060
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
Size
Outer Diameter — 4 Millimeter
Length — 8 Millimeter

Related devices

Category: Spinal fixation plate, non-bioabsorbable

Cleared under the same submission (K050391)

Show all (12)

Other devices from Globus Medical, Inc.

See all devices from Globus Medical, Inc. →

Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Lot / batch number

Other properties (11)

  • Supplied sterile: No
  • Contains latex: No
  • Prescription use: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No
  • Expiration date: No
  • Manufacturing date: No