FDA.reportPublic FDA data

AccuPlan System

Primary DI
00810007632124
Brand
AccuPlan System
Company
Medcad
Model
ZB-KT030-H
Catalog number
ZB-KT030-H
Device description
ORTHOPEDIC, TITANIUM HYBRID SURGICAL GUIDE, GRAFT
Published
2023-11-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LLZSystem, Image Processing, Radiological
PBFOrthopaedic Surgical Planning And Instrument Guides

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2
PBFOrthopaedic Surgical Planning And Instrument GuidesOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K223421000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223421000MedCAD AccuPlan Orthopedics SystemMedcad2023-09-20PBF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810007632124PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810007632124008100076321248100076321240810007632124

GMDN Terms#

Term, Definition table
TermDefinition
Custom-made organ/bone anatomy model/surgical guide kitA collection of custom-made devices intended to be used to assist anatomical visualization, surgical treatment planning, and intraoperative surgical procedures (e.g., orientation of implant components, guiding of surgical instruments). It consists of an anatomy model(s) of an organ/bone and an orthopaedic/craniomaxillofacial surgical guide(s) [e.g., for osteotomy, arthroplasty]; it is made of synthetic polymer materials and is 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 intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
(214) 453-8864support@medcad.com

Regulatory Flags#

DUNS number
144723868
Device count
1
Lot or batch
true
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810007633282AccuStride SystemMC-3D132MC-3D1322025-06-30
00810007633299AccuStride SystemMC-3D133MC-3D1332025-06-30
00810007633305AccuStride SystemMC-3D134MC-3D1342025-06-30
00810007633312AccuStride SystemMC-3D131MC-3D1312025-06-30
00810007633244AccuStride SystemMC-KST000MC-KST0002025-06-10
00081000763324AccuStride SystemMC-KST000MC-KST0002025-05-05
00810007633251AccuStride SystemMC-KST000-RMC-KST000-R2025-05-05
00810007633268AccuStride SystemMC-KST001MC-KST0012025-05-05
00810007633442AccuStride System MC-KSP003MC-KSP0032026-02-20
00810007633398AccuStride System MC-STP001MC-STP0012026-02-04
00810007633404AccuStride System MC-STP002MC-STP0022026-02-04
00810007633411AccuStride System MC-KSP000MC-KSP0002026-02-04
00810007633428AccuStride System MC-KSP001MC-KSP0012026-02-04
00810007633435AccuStride System MC-KSP002MC-KSP0022026-02-04
00810007633343AccuPlan SystemMC-3D217MC-3D2172025-10-31
00810007633350AccuPlan SystemMC-3D218MC-3D2182025-10-31
00810007633367AccuPlan SystemZB-3D217ZB-3D2172025-10-31
00810007633374AccuPlan SystemZB-3D218ZB-3D2182025-10-31
00810007633381AccuPlan SystemZB-KFITZB-KFIT2025-10-31
00810007633336AccuPlan System MC-KFITMC-KFIT2025-10-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00754016387128ANDIImeka Solutions IncLLZ2026-05-14
00198953059173ViewPointGE Healthcare GmbHLLZ2026-02-27
00810007633282AccuStride SystemMedcadPBF2025-06-30
00810007633299AccuStride SystemMedcadPBF2025-06-30
00810007633305AccuStride SystemMedcadPBF2025-06-30
00810007633312AccuStride SystemMedcadPBF2025-06-30
00810007633244AccuStride SystemMedcadPBF2025-06-10
00810111224680TMC PSI Cut Guide SystemTreace Medical Concepts, Inc.PBF2025-05-22
00810111224697TMC PSI Cut Guide SystemTreace Medical Concepts, Inc.PBF2025-05-22
00081000763324AccuStride SystemMedcadPBF2025-05-05
00810007633251AccuStride SystemMedcadPBF2025-05-05
00810007633268AccuStride SystemMedcadPBF2025-05-05
00198715251623BrainSpec Core™ SoftwareBrainSpec Inc.LLZ2025-02-10
00670082000610Modus PlanSynaptive Medical IncLLZ2025-01-17
00810111223553TMC PSI Cut Guide SystemTreace Medical Concepts, Inc.PBF2024-11-15
00810111223560TMC PSI Cut Guide SystemTreace Medical Concepts, Inc.PBF2024-11-15
00810111223577TMC PSI Cut Guide SystemTreace Medical Concepts, Inc.PBF2024-11-15
00810111223584TMC PSI Cut Guide SystemTreace Medical Concepts, Inc.PBF2024-11-15
00810111223447TMC PSI Cut Guide SystemTreace Medical Concepts, Inc.PBF2024-11-14
00810111223454TMC PSI Cut Guide SystemTreace Medical Concepts, Inc.PBF2024-11-14
00810111223478TMC PSI Cut Guide SystemTreace Medical Concepts, Inc.PBF2024-11-14
00810111223621TMC PSI Cut Guide SystemTreace Medical Concepts, Inc.PBF2024-11-14
00195278753472ViewPointGE Healthcare GmbHLLZ2024-07-15
00810111222723TMC PSI Cut Guide SystemTreace Medical Concepts, Inc.PBF2024-03-11
00810111222730TMC PSI Cut Guide SystemTreace Medical Concepts, Inc.PBF2024-03-11
00810111222259TMC PSI Cut Guide SystemTreace Medical Concepts, Inc.PBF2023-11-17
00810111222266TMC PSI Cut Guide SystemTreace Medical Concepts, Inc.PBF2023-11-17
00810111222273TMC PSI Cut Guide SystemTreace Medical Concepts, Inc.PBF2023-11-17
00810111222280TMC PSI Cut Guide SystemTreace Medical Concepts, Inc.PBF2023-11-17
00810111222297TMC PSI Cut Guide SystemTreace Medical Concepts, Inc.PBF2023-11-17