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Coriograph

FDA UDI

Class II (US FDA UDI)

by Smith & Nephew, Inc.

Identity

Trade Name
CORIOGRAPH FDA UDI
Generic Name
Orthopaedic/craniofacial implantation planning software FDA UDI
Device Name
CORIOGRAPH Pre-Operative Planning and Modeling Services V2.0. Modules in scope: CORIOGRAPH Knee Pre-Op Plan CORIOGRAPH Hip Pre-Op Plan CORIOGRAPH Modeler FDA UDI
Model / Reference
ROB2003002 FDA UDI
Description
CORIOGRAPH Pre-Operative Planning and Modeling Services V2.0. Modules in scope: CORIOGRAPH Knee Pre-Op Plan CORIOGRAPH Hip Pre-Op Plan CORIOGRAPH Modeler FDA UDI

Identifiers

Catalog Number
ROB2003002 FDA UDI
Primary DI / UDI-DI
00885556921524 FDA UDI
FDA Product Code
PBF FDA UDI
JDI FDA UDI
LZO FDA UDI
MBL FDA UDI
MEH FDA UDI
LWJ FDA UDI
LPH FDA UDI
KWZ FDA UDI
GMDN Term
Orthopaedic/craniofacial implantation planning software FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3030 FDA UDI
888.3350 FDA UDI
888.3353 FDA UDI
888.3358 FDA UDI
888.3360 FDA UDI
888.3310 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

Yes

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/craniofacial implantation planning software

Coriograph by Smith & Nephew, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic/craniofacial implantation planning software.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Smith & Nephew, Inc.

Sources (1)

  • FDA UDI 96fcb4de-a8a6-41f4-a8d4-743b61392cee 35 fields · synced Jun 8, 2026