FDA.reportPublic FDA data

3D-CUT

Primary DI
05400550150623
Brand
3D-CUT
Company
3D-Side
Model
AR-13402PSG
Device description
3D-Cut Patient-specific surgical guide - Lollipop and Bone model for Arthrex DFO PeekPower
Published
2026-04-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

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
K212237000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K2122370003D-Cut3D-Side S.A.2021-11-29PBF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05400550150623PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05400550150623054005501506235400550150623

GMDN Terms#

Term, Definition table
TermDefinition
Custom-made orthopaedic/craniofacial surgical guideA custom-made surgical instrument intended to be used in an orthopaedic and/or craniomaxillofacial procedure (e.g., osteotomy, arthroplasty, tumour resection, distraction osteogenesis, cranial vault reconstruction) to assist in the intraoperative orientation of implant components, outlining the desired cut-line, and/or guiding of surgical instruments (e.g., surgical drill, oscillating cutting saw). It is typically manufactured by 3-D printing and CAD/CAM techniques to match the patient-specific contours of the target anatomical site. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a dry place

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1 (303) 482-6785jason.lansdown@3dside.eu

Regulatory Flags#

DUNS number
370732776
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
054005500102173D-CUT02-PSI-T2026-04-28
054005501506163D-CUTAR-13100PSG2026-04-28
054005501506303D-CUTAR-13700PSG2026-04-28
054005501506473D-CUTAR-13200PSG2026-04-28
054005501506543D-CUTAR-13400PSG2026-04-28
054005501506613D-CUTAR-13401PSG2026-04-28

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
00885556925379CORIOGRAPHSmith & Nephew, Inc.PBF2026-07-08
00885556925386CORIOGRAPHSmith & Nephew, Inc.PBF2026-07-08
054005500102173D-CUT3D-SidePBF2026-04-28
054005501506163D-CUT3D-SidePBF2026-04-28
054005501506303D-CUT3D-SidePBF2026-04-28
054005501506473D-CUT3D-SidePBF2026-04-28
054005501506543D-CUT3D-SidePBF2026-04-28
054005501506613D-CUT3D-SidePBF2026-04-28
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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