FDA.reportPublic FDA data

TECHFIT

Primary DI
00860014930911
Brand
TECHFIT
Company
Techfit Digital Surgery, Inc.
Model
0
Catalog number
BECCXLPEEK
Device description
Patient Match Cranial Implant, XL, 200-250 cm^2 PEEK
Published
2025-12-30
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Safe
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
GWOPlate, Cranioplasty, Preformed, Alterable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWOPlate, Cranioplasty, Preformed, AlterableNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K250297000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250297000TECHFIT Patient-Specific Cranial SystemTechfit Digital Surgery, Inc.2025-10-27GWO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860014930911PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860014930911008600149309118600149309110860014930911

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
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
00860011469254TECHFIT0MAPMAXI2024-02-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810125929892CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-07-13
00810125929908FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-07-13
00810125929915CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-07-13
00810125929922CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-07-13
00810125929939CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-07-13
00810125929946CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-07-13
00810125929953CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-07-13
00810125929960CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-07-13
00810125929977CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-07-13
00810125929984CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-07-13
00810125929861CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-07-06
00810125929878CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-07-06
00810125929885CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-07-06
00810125929823CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-06-24
00810125929830FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-06-24
00810125929847CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-06-24
00810125929854CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-06-24
00810125929687CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-06-10
00810125929694CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-06-10
00810125929700CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-06-10
00810125929717FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-06-10
00810125929724CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-06-10
00810125929731CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-06-10
00810125929748FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-06-10
00810125929755CUSTOMIZED CRANIOFACIAL IMPLANT (CCI)KELYNIAM GLOBAL, INC.GWO2026-06-10
00810125929663CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-06-02
00810125929670FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-06-02
00810125929625CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-06-01
00810125929632CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-06-01
00810125929649CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-06-01