FDA.reportPublic FDA data

CORIOGRAPH

Primary DI
00885556925379
Brand
CORIOGRAPH
Company
Smith & Nephew, Inc.
Model
ROB20032
Catalog number
ROB20032
Device description
CORIOGRAPH Pre-Op Planning and Modeling Services for Hip
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
00885556925379PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885556925379008855569253798855569253790885556925379

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
00885556819845Uni-CP Compression Plate286322ND286322ND2023-11-07
00885556819852Uni-CP Compression Plate286324ND286324ND2023-11-07
00885556819869Uni-CP Compression Plate286326ND286326ND2023-11-07
00885556819876Uni-CP Compression Plate286328ND286328ND2023-11-07
00885556819883Uni-CP Compression Plate286330ND286330ND2023-11-07
00885556819890Uni-CP Compression Plate286332ND286332ND2023-11-07
00885556819906Uni-CP Compression Plate286334ND286334ND2023-11-07
00885556819357General Instruments219865ND219865ND2023-10-27
00885556846599Total Wrist Fusion186200ND186200ND2023-10-27
00885556910245UNI-CP Compression Plate186300ND186300ND2023-10-27
00885556819722Total Wrist Fusion286220ND286220ND2023-10-26
00885556819746Total Wrist Fusion286222ND286222ND2023-10-26
00885556819760Total Wrist Fusion286224ND286224ND2023-10-26
00885556819807UNI-CP Compression Plate286314ND286314ND2023-10-26
00885556819814UNI-CP Compression Plate286316ND286316ND2023-10-26
00885556819821UNI-CP Compression Plate286318ND286318ND2023-10-26
00885556819838UNI-CP Compression Plate286320ND286320ND2023-10-26
00885556847329UNI-CP Compression Plate219535ND219535ND2023-10-26
00885556819623Total Wrist Fusion286210ND286210ND2023-10-25
00885556819647SURFIXTotal Wrist Fusion286212ND286212ND2023-10-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00688346003918Fine TTOLaboratoires Bodycad IncPBF2026-08-03
00688346005356Fine Osteotomy System - Femoral plateLaboratoires Bodycad IncPBF2026-08-03
00688346005387Fine Osteotomy System - Femoral plateLaboratoires Bodycad IncPBF2026-08-03
00688346005523Fine Osteotomy System - Tibial plateLaboratoires Bodycad IncPBF2026-08-03
00688346005554Fine Osteotomy System - Tibial plateLaboratoires Bodycad IncPBF2026-08-03
00885556925386CORIOGRAPHSmith & Nephew, Inc.PBF2026-07-08
054005500102173D-CUT3D-SidePBF2026-04-28
054005501506163D-CUT3D-SidePBF2026-04-28
054005501506233D-CUT3D-SidePBF2026-04-28
054005501506303D-CUT3D-SidePBF2026-04-28
054005501506473D-CUT3D-SidePBF2026-04-28
054005501506543D-CUT3D-SidePBF2026-04-28
054005501506613D-CUT3D-SidePBF2026-04-28
00840124525542FibFixFUSION ORTHOPEDICS, LLCPBF2026-04-23
00840124525559FibFixFUSION ORTHOPEDICS, LLCPBF2026-04-23
00840124525566FuzeFix LargeFUSION ORTHOPEDICS, LLCPBF2026-04-23
00840124525597FuzeFix LargeFUSION ORTHOPEDICS, LLCPBF2026-04-23
00840124516779FibFixFUSION ORTHOPEDICS, LLCPBF2026-04-09
00840124517783FibFixFUSION ORTHOPEDICS, LLCPBF2026-04-09
00840124525467FibFixFUSION ORTHOPEDICS, LLCPBF2026-04-09
00860009815780EmbedMed3D LIFEPRINTS UK LTDPBF2026-03-30
00840124521773PolyLock MidfootFUSION ORTHOPEDICS, LLCPBF2025-10-02
00840124521780PolyLock MidfootFUSION ORTHOPEDICS, LLCPBF2025-10-02
00840124521797PolyLock MidfootFUSION ORTHOPEDICS, LLCPBF2025-10-02
00840124521803PolyLock MidfootFUSION ORTHOPEDICS, LLCPBF2025-10-02
00840124521810PolyLock MidfootFUSION ORTHOPEDICS, LLCPBF2025-10-02
00840124521827PolyLock MidfootFUSION ORTHOPEDICS, LLCPBF2025-10-02
00840124521834PolyLock MidfootFUSION ORTHOPEDICS, LLCPBF2025-10-02
00840124521841PolyLock MidfootFUSION ORTHOPEDICS, LLCPBF2025-10-02
00810007633282AccuStride SystemMedcadPBF2025-06-30