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Xpand 116.125

by Globus Medical, Inc.

Xpand 116.125 is a Class II device made by Globus Medical, Inc., cleared under FDA 510(k) K050850 on 26 May 2005 and listed in FDA GUDID since 9 Oct 2015 (UDI-DI 00849044022698), active as of 23 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 23 Oct 2026

Documents

510(k) K050850

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00849044022698 UDI-DI Date9 Oct 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK050850 Date26 May 2005DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K050850 decided 26 May 2005 Active
  • FDA GUDID UDI-DI 00849044022698 listed 9 Oct 2015 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K050850
  2. Listed FDA GUDID 00849044022698

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Xpand
Generic name
Vertebral body prosthesis
Model / reference
116.125
Primary DI / UDI-DI
00849044022698
510(k) Number
FDA product code
MQP
GMDN term
Vertebral body prosthesis
Device class
Class II
Regulation number
888.3060
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
Size
Height — 19 Millimeter
Depth — 12 Millimeter
Width — 14 Millimeter

Related devices

Category: Vertebral body prosthesis

Cleared under the same submission (K050850)

and 8 more cleared under K050850

Similar devices

Other devices filed under FDA product code MQP (SPINAL VERTEBRAL BODY REPLACEMENT DEVICE).

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, all answered No)