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Xrl 08.807.325S

by Synthes

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

1 closed

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10705034755717 UDI-DI Date14 Sep 2015ListedStatusListed GUDID: in commercial distribution

Recalls

1 recall · FDA

    • Terminated Z-1681-2014 FDA Class II initiated 8 Apr 2014

    Two lots of the Synthes XRL Medium Trial-Central Body device were incorrectly etched with the incorrect dimensions for height.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Xrl
Generic Name
Vertebral body prosthesis
Model / Ref / Catalog
08.807.325S, 08807325S
Primary DI / UDI-DI
10705034755717
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

Related devices

Category: Vertebral body prosthesis

Cleared under the same submission (K103320)

Show all (12)

Other devices from Synthes

See all devices from Synthes →

Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (8)

  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No