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Plexur P® 60000320INT

by Medtronic Sofamor Danek, Inc.

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

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 Number00643169218093 UDI-DI Date2 Apr 2016ListedStatusListed GUDID: not in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Plexur P®
Generic Name
Human-derived demineralized bone matrix implant
Model / Reference
60000320INT
Primary DI / UDI-DI
00643169218093
510(k) Number
FDA Product Code
MQV
GMDN Term
Human-derived demineralized bone matrix implant
Device Class
Class II
Regulation Number
888.3045
GUDID distribution status
Not in Commercial Distribution
MRI Safety
MR Safe

Related devices

Cleared under the same submission (K080511)

Other devices from Medtronic Sofamor Danek, Inc.

See all devices from Medtronic Sofamor Danek, Inc. →

Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • HCT/P
  • Serial Number

Other properties (8)

  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No