FDA.reportPublic FDA data

CORIOGRAPH

Primary DI
00885556925386
Brand
CORIOGRAPH
Company
Smith & Nephew, Inc.
Model
ROB20031
Catalog number
ROB20031
Device description
CORIOGRAPH Pre-Op Planning and Modeling Services for Knee
Published
2026-07-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
PBFOrthopaedic surgical planning and instrument guides

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PBFOrthopaedic Surgical Planning And Instrument GuidesOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K250921000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250921000CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc.2025-06-25PBF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00885556925386PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885556925386008855569253868855569253860885556925386

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic/craniofacial implantation planning softwareA software program intended to add specific computer-assisted display, processing, and/or analysis capabilities to prepare for the implantation of an orthopaedic and/or craniomaxillofacial (CMF) prosthesis. Using digitized x-rays or imported computed tomography (CT) images, it provides implant-site anatomical images, and using computerized files representing implant patterns, provides the surgeon with images that help determine the appropriate size and placement of the implant.

Contacts#

Phone, Email table
PhoneEmail
+1(800)238-7538GUDID@SMITH-NEPHEW.COM

Regulatory Flags#

DUNS number
045483575
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00885556925379CORIOGRAPHROB20032ROB200322026-07-08
00885556904879EVOS70887105708871052026-06-25
00885556904923EVOS70897130708971302026-06-25
00885556906163EVOS70879090708790902026-06-25
00885556906170EVOS70879095708790952026-06-25
00885556906187EVOS70879100708791002026-06-25
00885556906194EVOS70879105708791052026-06-25
00885556906200EVOS70879110708791102026-06-25
00885556906217EVOS70879115708791152026-06-25
00885556906224EVOS70879120708791202026-06-25
00885556906231EVOS70879125708791252026-06-25
00885556906248EVOS70879130708791302026-06-25
00885556906255EVOS70879135708791352026-06-25
00885556906262EVOS70879140708791402026-06-25
00885556906279EVOS70879145708791452026-06-25
00885556906286EVOS70879150708791502026-06-25
00885556906293EVOS70879155708791552026-06-25
00885556906309EVOS70879160708791602026-06-25
00885556906316EVOS70879165708791652026-06-25
00885556906323EVOS70879170708791702026-06-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00885556925379CORIOGRAPHSmith & Nephew, Inc.PBF2026-07-08
07630345779939NextAR Spine Platform Medacta International SAPBF2023-07-24
07630345797063NextAR Spine Platform Medacta International SAPBF2023-07-24
07630345797070NextAR Spine Platform Medacta International SAPBF2023-07-24
07630345797087NextAR Spine Platform Medacta International SAPBF2023-07-24
G2710300240140IntelliguidesMios Marketing, LLCPBF2023-01-01
G2710310240150IntelliguidesMios Marketing, LLCPBF2023-01-01
G2710310240160IntelliguidesMios Marketing, LLCPBF2023-01-01
G2710310240180IntelliguidesMios Marketing, LLCPBF2023-01-01
G2710310240190IntelliguidesMios Marketing, LLCPBF2023-01-01
G2710310240200IntelliguidesMios Marketing, LLCPBF2023-01-01
G2710310240210IntelliguidesMios Marketing, LLCPBF2023-01-01
G2710310240220IntelliguidesMios Marketing, LLCPBF2023-01-01
G2710310240230IntelliguidesMios Marketing, LLCPBF2023-01-01
G2710310240240IntelliguidesMios Marketing, LLCPBF2023-01-01
G2710310240250IntelliguidesMios Marketing, LLCPBF2023-01-01
G2710310260150IntelliguidesMios Marketing, LLCPBF2023-01-01
G2710310260160IntelliguidesMios Marketing, LLCPBF2023-01-01
G2710310260170IntelliguidesMios Marketing, LLCPBF2023-01-01
G2710310260180IntelliguidesMios Marketing, LLCPBF2023-01-01
G2710310260190IntelliguidesMios Marketing, LLCPBF2023-01-01
G2710310260200IntelliguidesMios Marketing, LLCPBF2023-01-01
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G2710310260220IntelliguidesMios Marketing, LLCPBF2023-01-01
G2710310260230IntelliguidesMios Marketing, LLCPBF2023-01-01
G2710310260240IntelliguidesMios Marketing, LLCPBF2023-01-01
G2710310260250IntelliguidesMios Marketing, LLCPBF2023-01-01
G2710310280150IntelliguidesMios Marketing, LLCPBF2023-01-01
G2710310280160IntelliguidesMios Marketing, LLCPBF2023-01-01
G2710310280170IntelliguidesMios Marketing, LLCPBF2023-01-01