FDA.reportPublic FDA data

TECHFIT

Primary DI
00860007543425
Brand
TECHFIT
Company
Techfit Digital Surgery, Inc.
Model
0
Catalog number
BETMCT
Device description
Patient-Specific Maxillofacial/midface implant-Ti
Published
2023-06-15
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
JEYPlate, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JEYPlate, BoneDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K203282000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203282000TECHFIT Patient-Specific Maxillofacial SystemIndustrias Medicas Sampedro S.A.S2021-05-19JEY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860007543425PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860007543425008600075434258600075434250860007543425

GMDN Terms#

Term, Definition table
TermDefinition
Custom-made cranial bone prosthesisAn implantable device intended to repair a defect of the cranium or mandible that is designed and constructed with specific characteristics (e.g., size, shape, material) as prescribed by a healthcare provider for a specified patient. It is typically manufactured from a three-dimensional (3-D) model based on computed tomography (CT) images and made of plastic [e.g., ultrahigh molecular weight polyethylene (UHMWPE), polyetheretherketone (PEEK)] and/or metal [e.g., titanium (Ti)]. The device may be used to repair defects due to injury, surgical intervention for tumour removal, congenital anomaly, or disease, or for cosmetic/aesthetic purposes.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
117050279
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860011469261TECHFIT0GCSDTI2024-02-22
00860011469278TECHFIT0GASDSTI2024-02-22
00860011469292TECHFIT0MAP3DD2025-10-10
00860012759477TECHFIT0BECCPEEK2025-12-30
00860012759484TECHFIT0BECCMPEEK2025-12-30
00860012759491TECHFIT0BECCMLPEEK2025-12-30
00860014930904TECHFIT0BECACPEEK2025-12-30
00860014930911TECHFIT0BECCXLPEEK2025-12-30
00860014930928TECHFIT0BECCX2PEEK2025-12-30
00860014930935TECHFIT0MAPCDCL2025-12-30
00860014930942TECHFIT0MAPCC2025-12-30
00860012759446TECHFIT0GCPTI2025-03-17
00860012759453TECHFIT0GCMANTI2025-03-17
00860012759460TECHFIT0GCMAXTI2025-03-17
00860012759439TECHFIT0DISRP2025-03-10
00860012759408TECHFIT0FFCOD2024-09-13
00860012759415TECHFIT0FICOD2024-09-13
00860012759422TECHFIT0FPCOD2024-09-13
00860011469285TECHFIT0CGPTI2024-08-28
00860011469247TECHFIT0MAPMANI2024-02-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809233620106ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620113ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620120ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620137ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620144ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620151ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620168ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620182ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620199ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620205ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620298ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620304ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620311ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620335ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620342ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620366ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620380ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620397ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620403ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620410ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620427ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620489ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620502ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620526ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620533ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620540ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620557ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620625ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620632ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620649ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11