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Blueprint

FDA UDI

Class II (US FDA UDI)

by Tornier, Inc.

Identity

Trade Name
Blueprint FDA UDI
Generic Name
Orthopaedic CAD/CAM system FDA UDI
Device Name
MAC FDA UDI
Model / Reference
BPUE001 FDA UDI
Description
MAC FDA UDI

Identifiers

Catalog Number
4.1.Mac FDA UDI
Primary DI / UDI-DI
03700434023107 FDA UDI
510(k) Number
K232265 FDA UDI
FDA Product Code
KWS FDA UDI
PHX FDA UDI
QHE FDA UDI
GMDN Term
Orthopaedic CAD/CAM system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3660 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Orthopaedic CAD/CAM system

Blueprint by Tornier, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic CAD/CAM system.

Cleared under the same submission

K232265 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Tornier, Inc.

Sources (1)

  • FDA UDI 01c7a3e8-c17f-4e61-9c11-79e5d3fcf751 36 fields · synced Jun 8, 2026