FDA.reportPublic FDA data

AccuPlan System

Primary DI
00810007632261
Brand
AccuPlan System
Company
Medcad
Model
ZB-KTP010
Catalog number
ZB-KTP010
Device description
ORTHOGNATHIC, SURGICAL PLANNING KIT W/ 3D PRINTED TITANIUM PLATES AND TITANIUM GUIDES, SINGLE JAW
Published
2023-11-01
Public version status
Update
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
DZJDriver, Wire, And Bone Drill, Manual
JEYPlate, Bone
LLZSystem, Image Processing, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZJDriver, Wire, And Bone Drill, ManualDental2
JEYPlate, BoneDental2
LLZSystem, Image Processing, RadiologicalRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810007632261PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810007632261008100076322618100076322610810007632261

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
00884838120433SmartCTPhilips Medical Systems Nederland B.V.LLZ2026-09-28
00888118155498IPSKLS-Martin L.P.DZJ2026-09-28
00888118155498IPSKLS-Martin L.P.JEY2026-09-28
00888118155504IPSKLS-Martin L.P.JEY2026-09-28
00888118155504IPSKLS-Martin L.P.DZJ2026-09-28
00888118155511IPSKLS-Martin L.P.JEY2026-09-28
00888118155511IPSKLS-Martin L.P.DZJ2026-09-28
00888118155528IPSKLS-Martin L.P.DZJ2026-09-28
00888118155528IPSKLS-Martin L.P.JEY2026-09-28
00888118155535IPSKLS-Martin L.P.JEY2026-09-28
00888118155535IPSKLS-Martin L.P.DZJ2026-09-28
00888118155542IPSKLS-Martin L.P.DZJ2026-09-28
00888118155542IPSKLS-Martin L.P.JEY2026-09-28
00888118155559IPSKLS-Martin L.P.DZJ2026-09-28
00888118155559IPSKLS-Martin L.P.JEY2026-09-28
00888118155566IPSKLS-Martin L.P.DZJ2026-09-28
00888118155566IPSKLS-Martin L.P.JEY2026-09-28
04260456230215CHILI PACSCHILI GmbHLLZ2026-09-25
B141MEDISSUITEMRCT20260Medis Suite MRCTMedis Medical Imaging Systems B.V.LLZ2026-09-25
07613327711578NAStryker Leibinger GmbH & Co. KGJEY2026-09-24
07613327711585NAStryker Leibinger GmbH & Co. KGJEY2026-09-24
07613327711592NAStryker Leibinger GmbH & Co. KGJEY2026-09-24
07613327711608NAStryker Leibinger GmbH & Co. KGJEY2026-09-24
00850025268431Vitrea Advanced VisualizationCanon Medical Informatics, Inc.LLZ2026-09-21
08437021722109ADAS 3DADAS3D MEDICAL S.L.LLZ2026-09-18
07350092810722Sectra Orthopedic PackageSectra ABLLZ2026-09-06
00754016387128ANDIImeka Solutions IncLLZ2026-05-14
00198953059173ViewPointGE Healthcare GmbHLLZ2026-02-27
00198953076873SenoIrisGE MEDICAL SYSTEMSLLZ2025-11-24
00195278951700EchoPACGE Vingmed Ultrasound A/SLLZ2025-08-08