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Blueprint BPUE001

by Tornier, Inc. 10 variants

Listed FDA GUDID listing, no authorization on record

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 Number03700434023855 UDI-DI Date11 Jun 2026ListedStatusListed GUDID: 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  • Withdrawn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
Blueprint
Generic Name
Orthopaedic CAD/CAM system
Model / Ref / Catalog
BPUE001, 4.3.Mac
Primary DI / UDI-DI
03700434023855
510(k) Number
FDA Product Code
KWS, QHE, PHX
GMDN Term
Orthopaedic CAD/CAM system
Device Class
Class II
Regulation Number
888.3660
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K253674)

Other devices from Tornier, Inc.

See all devices from Tornier, Inc. →

Properties

  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: 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