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2.0mm System Sp-3084

by Biomet Microfixation, Inc 2 variants

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 Number00888233021838 UDI-DI Date17 Jun 2020ListedStatusListed GUDID: in commercial distribution

Recalls

1 recall · FDA

    • Terminated Z-1220-2017 FDA Class II initiated 10 Jan 2017 on shared 510(k) K121589

    The identification of the devices was non-conforming with off-centered slots and the no-go gage starting in the pilot hole.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
2.0mm System
Generic Name
Craniofacial fixation plate, non-bioabsorbable, non-customized
Model / Ref / Catalog
SP-3084
Primary DI / UDI-DI
00888233021838
510(k) Number
FDA Product Code
JEY
GMDN Term
Craniofacial fixation plate, non-bioabsorbable, non-customized
Device Class
Class II
Regulation Number
872.4760
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Category: Craniofacial fixation plate, non-bioabsorbable, non-customized

Cleared under the same submission (K121589)

Show all (12)

Other devices from Biomet Microfixation, Inc

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Properties

  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number

Other properties (10)

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