FDA.reportPublic FDA data

AccuStride System

Primary DI
00810007633442
Brand
AccuStride System
Company
Medcad
Model
MC-KSP003
Catalog number
MC-KSP003
Device description
Lapidus Surgical Planning Kit
Published
2026-02-20
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
HRSPlate, Fixation, Bone
PBFOrthopaedic Surgical Planning And Instrument Guides

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2
PBFOrthopaedic Surgical Planning And Instrument GuidesOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K251709000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K251709000MedCAD® AccuStride™ SystemMedcad2025-11-04PBF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810007633442PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810007633442008100076334428100076334420810007633442

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic fixation plate, non-bioabsorbableA non-bioabsorbable, non-customized, firm, implantable sheet intended to stabilize a fractured orthopaedic bone (excluding craniofacial and spinal) to treat a traumatic/pathological fracture, to fuse a joint (arthrodesis) and/or as part of an osteotomy. Typically attached to a bone of a limb, rib, sternum, or pelvis, it is designed to be fixed in place with screws, and may be used in connection with another fixation plate; it does not incorporate a sleeve or blade. Disposable instruments intended to facilitate implantation, or fixation implants (i.e., bone screws), may be packaged with the plate.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
144723868
Device count
1
Lot or batch
true
Serial number
true
Expiration date on label
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
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
00810007633329AccuStride System MC-STP001MC-STP0012025-08-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00840124514720PolyLock MidfootFUSION ORTHOPEDICS, LLCPBF2025-01-07
00840124514737PolyLock MidfootFUSION ORTHOPEDICS, LLCPBF2025-01-07
00840124514706FuzeFix Chamfered ScrewFUSION ORTHOPEDICS, LLCPBF2024-12-13
00840124514713FuzeFix Chamfered ScrewsFUSION ORTHOPEDICS, LLCPBF2024-12-13
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
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
00810111222327TMC PSI Cut Guide SystemTreace Medical Concepts, Inc.PBF2023-11-17