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Biostop 5463-16-000

by Depuy Orthopaedics, Inc.

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

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 Number10603295174585 UDI-DI Date24 Sep 2015ListedStatusListed GUDID: not in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Biostop
Generic Name
Polymer orthopaedic cement restrictor, bioabsorbable
Model / Ref / Catalog
5463-16-000, 546316000
Primary DI / UDI-DI
10603295174585
FDA Product Code
LZN, JDK
GMDN Term
Polymer orthopaedic cement restrictor, bioabsorbable
Device Class
Class II
Regulation Number
878.3300
GUDID distribution status
Not in Commercial Distribution

Other devices from Depuy Orthopaedics, Inc.

See all devices from Depuy Orthopaedics, Inc. →

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