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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-OP PLANNING AND MODELING SERVICE FDA UDI
Model / Reference
ROB20030 FDA UDI
Description
CORIOGRAPH PRE-OP PLANNING AND MODELING SERVICE FDA UDI

Identifiers

Catalog Number
ROB20030 FDA UDI
Primary DI / UDI-DI
00885556917442 FDA UDI
510(k) Number
K240113 FDA UDI
FDA Product Code
PBF FDA UDI
OOG FDA UDI
MBH FDA UDI
JWH FDA UDI
HSX FDA UDI
GMDN Term
Orthopaedic/craniofacial implantation planning software FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3030 FDA UDI
888.3560 FDA UDI
888.3565 FDA UDI
888.3520 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 7e20460d-7dcc-4cca-8e95-35fcd59923fc 36 fields · synced Jun 8, 2026