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Expedium 188112640

by Depuy Spine, Inc.

Expedium 188112640 is a Class II device made by Depuy Spine, Inc., cleared under FDA 510(k) K111136 on 14 Jun 2012 (1 earlier submission) and listed in FDA GUDID since 24 Sep 2015 (UDI-DI 10705034146805), active (FDA 510(k)), not in commercial distribution (GUDID) as of 23 Oct 2026. One FDA recall is linked to it.

Active United States. Also listed in GUDID (US), not in commercial distribution.

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10705034146805 UDI-DI Date24 Sep 2015ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESU from GUDID Traditional NumberK111136 Date14 Jun 2012DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K111136 decided 14 Jun 2012 Active· +1 more in the status table
  • FDA GUDID UDI-DI 10705034146805 listed 24 Sep 2015 Listed

Recalls

1 recall · FDA

    • Terminated Z-1674-2015 FDA Class II initiated 21 Apr 2015

    Device does not mate as intended.

Timeline

4 dated events

  1. Cleared FDA 510(k) K041119
  2. Cleared FDA 510(k) K111136
  3. Recall initiated FDA recalls Z-1674-2015
  4. Listed FDA GUDID 10705034146805

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Expedium
Generic name
Bone-screw internal spinal fixation system, non-sterile
Model / Ref / Catalog
188112640
Primary DI / UDI-DI
10705034146805
510(k) Number
FDA product code
MNI, MNH, NKB, KWP, OSH, KWQ
GMDN term
Bone-screw internal spinal fixation system, non-sterile
Device class
Class II
Regulation number
888.3070, 888.3050, 888.3060
GUDID distribution status
Not in Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Cleared under the same submission (K111136)

and 8 more cleared under K111136

Similar devices

Other devices filed under FDA product code MNI (ORTHOSIS, SPINAL PEDICLE FIXATION).

Other devices from Depuy Spine, Inc.

See all devices from Depuy Spine, Inc. →

Properties

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