FDA.reportPublic FDA data

TECHFIT

Primary DI
00860007543463
Brand
TECHFIT
Company
Techfit Digital Surgery, Inc.
Model
0
Catalog number
GCLRBC
Device description
Le Fort Surgical Guide - Slots Resin
Published
2023-08-04
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
DZJDriver, Wire, And Bone Drill, Manual
LLZSystem, Image Processing, Radiological

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K230276000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230276000TECHFIT DISRP® SystemTechfit Digital Surgery2023-06-23DZJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860007543463PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860007543463008600075434638600075434630860007543463

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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
117050279
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
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
00860011469261TECHFIT0GCSDTI2024-02-22
00860011469278TECHFIT0GASDSTI2024-02-22
00860012759446TECHFIT0GCPTI2025-03-17
00860012759453TECHFIT0GCMANTI2025-03-17
00860012759460TECHFIT0GCMAXTI2025-03-17
00860012759439TECHFIT0DISRP2025-03-10
00860012759408TECHFIT0FFCOD2024-09-13
00860012759415TECHFIT0FICOD2024-09-13
00860012759422TECHFIT0FPCOD2024-09-13
00860011469285TECHFIT0CGPTI2024-08-28
00860011469216TECHFIT0FPCOTI2024-02-06
00860011469223TECHFIT0FPCOBC2024-02-06
00860011469230TECHFIT0GCSTI2024-02-06
00860007543456TECHFIT0FFCOBC2023-08-04
00860007543470TECHFIT0GCLPBC2023-08-04
00860007543487TECHFIT0GCLRFBC2023-08-04
00860007543494TECHFIT0GCLPFBC2023-08-04
00860010801604TECHFIT0GCGBC2023-08-04
00860010801611TECHFIT0GCGFBC2023-08-04
00860010801628TECHFIT0GCLSDTI2023-08-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260456230215CHILI PACSCHILI GmbHLLZ2026-09-25
B141MEDISSUITEMRCT20260Medis Suite MRCTMedis Medical Imaging Systems B.V.LLZ2026-09-25
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
00860003424841OrthoGrid Hip TraumaOrthogrid Systems, Inc.LLZ2025-06-24
00884838127746Radiology Operations Command Center ConsolePhilips Medical Systems Nederland B.V.LLZ2025-03-14
00198715251623BrainSpec Core™ SoftwareBrainSpec Inc.LLZ2025-02-10
00670082000610Modus PlanSynaptive Medical IncLLZ2025-01-17
00195278753472ViewPointGE Healthcare GmbHLLZ2024-07-15
00350227000520EaglesoftPATTERSON TECHNOLOGY CENTERLLZ2023-10-25
00754016387111ANDIImeka Solutions IncLLZ2023-09-01
00195278517340ViewPointGE Healthcare GmbHLLZ2023-02-15
00670082000511Modus PlanSynaptive Medical IncLLZ2022-12-13
00860003424834OrthoGrid Hip AIOrthogrid Systems, Inc.LLZ2022-05-19
07649990819006OsiriX MDPixmeo SàrlLLZ2022-02-19
00860003424827OrthoGrid Hip TraumaOrthogrid Systems, Inc.LLZ2021-08-27
00860003424803OrthoGrid HipOrthogrid Systems, Inc.LLZ2021-03-05
00860003424810OrthoGrid Hip PreservationOrthogrid Systems, Inc.LLZ2021-03-05
00350227300071FUSEPATTERSON TECHNOLOGY CENTERLLZ2020-09-19
00817886020226JointsMEDSTRAT, INC.LLZ2020-08-03
00817886020233JointsMEDSTRAT, INC.LLZ2020-08-03
00817886020240JointsMEDSTRAT, INC.LLZ2020-08-03
00817886020257JointsMEDSTRAT, INC.LLZ2020-08-03
00817886020264JointsMEDSTRAT, INC.LLZ2020-08-03
00817886020271JointsMEDSTRAT, INC.LLZ2020-08-03
00350227300064FUSEPATTERSON TECHNOLOGY CENTERLLZ2020-06-02