FDA.reportPublic FDA data

TECHFIT

Primary DI
00860010801673
Brand
TECHFIT
Company
Techfit Digital Surgery, Inc.
Model
0
Catalog number
Q-SPCS
Device description
Slot metal sleeve
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
00860010801673PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860010801673008600108016738600108016730860010801673

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
00860007543463TECHFIT0GCLRBC2023-08-04
00860007543470TECHFIT0GCLPBC2023-08-04
00860007543487TECHFIT0GCLRFBC2023-08-04
00860007543494TECHFIT0GCLPFBC2023-08-04
00860010801604TECHFIT0GCGBC2023-08-04
00860010801611TECHFIT0GCGFBC2023-08-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719878712002OOOPDSTaiwan Main Orthopaedic Biotechnology Co., Ltd.LLZ2026-10-28
00889024671270ROSA® HipOrthosoft IncLLZ2026-10-27
00889024705999NavitrackerOrthosoft IncLLZ2026-10-26
05420060351235TRUMATCHMaterialise NVDZJ2026-10-22
05420060351235TRUMATCHMaterialise NVLLZ2026-10-22
05420060351242TRUMATCHMaterialise NVLLZ2026-10-22
05420060351242TRUMATCHMaterialise NVDZJ2026-10-22
05420060351259TRUMATCHMaterialise NVLLZ2026-10-22
05420060351259TRUMATCHMaterialise NVDZJ2026-10-22
05420060351266TRUMATCHMaterialise NVLLZ2026-10-22
05420060351266TRUMATCHMaterialise NVDZJ2026-10-22
05420060351273TRUMATCHMaterialise NVDZJ2026-10-22
05420060351273TRUMATCHMaterialise NVLLZ2026-10-22
05420060351280TRUMATCHMaterialise NVDZJ2026-10-22
05420060351280TRUMATCHMaterialise NVLLZ2026-10-22
05420060351297TRUMATCHMaterialise NVLLZ2026-10-22
05420060351297TRUMATCHMaterialise NVDZJ2026-10-22
05420060351303TRUMATCHMaterialise NVLLZ2026-10-22
05420060351303TRUMATCHMaterialise NVDZJ2026-10-22
05420060351310TRUMATCHMaterialise NVLLZ2026-10-22
05420060351310TRUMATCHMaterialise NVDZJ2026-10-22
05420060351327TRUMATCHMaterialise NVLLZ2026-10-22
05420060351327TRUMATCHMaterialise NVDZJ2026-10-22
05420060351334TRUMATCHMaterialise NVDZJ2026-10-22
05420060351334TRUMATCHMaterialise NVLLZ2026-10-22
05420060351341TRUMATCHMaterialise NVDZJ2026-10-22
05420060351341TRUMATCHMaterialise NVLLZ2026-10-22
05420060351358TRUMATCHMaterialise NVLLZ2026-10-22
05420060351358TRUMATCHMaterialise NVDZJ2026-10-22
05420060351365TRUMATCHMaterialise NVDZJ2026-10-22