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Plateau-C Ti 2008-1411-07

by Life Spine, 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 Number00190837067090 UDI-DI Date7 Nov 2019ListedStatusListed 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  • Withdrawn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
Plateau-C Ti
Generic Name
Polymer orthopaedic cement restrictor, non-bioabsorbable
Model / Ref / Catalog
2008-1411-07
Primary DI / UDI-DI
00190837067090
510(k) Number
FDA Product Code
ODP
GMDN Term
Polymer orthopaedic cement restrictor, non-bioabsorbable
Device Class
Class II
Regulation Number
888.3080
GUDID distribution status
Not in Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Cleared under the same submission (K161127)

Show all (12)

Other devices from Life Spine, Inc.

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Properties

  • Implantable
  • Prescription Use
  • Lot / Batch Number

Other properties (11)

  • Sterile: No
  • Single Use: 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