FDA.reportPublic FDA data

ClearFit

Primary DI
00855113008548
Brand
ClearFit
Company
LONGEVITI NEURO SOLUTIONS LLC
Model
171726
Device description
ClearFit OTS Disc Curved Large
Published
2023-03-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GXNPlate, Cranioplasty, Preformed, Non-Alterable
PJNFiller, Bone Void, Non-Alterable Compound For Cranioplasty

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXNPlate, Cranioplasty, Preformed, Non-AlterableNeurology2
PJNFiller, Bone Void, Non-Alterable Compound For CranioplastyNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K212058000
K231920000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212058000Longeviti ClearFit™ OTS Cranial ImplantsLongeviti Neuro Solutions, LLC2021-09-08GXN
K231920000Longeviti ClearFit OTS Cranial ImplantLongeviti Neuro Solutions, LLC2023-11-09GXN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00855113008548PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00855113008548008551130085488551130085480855113008548

GMDN Terms#

Term, Definition table
TermDefinition
Cranial resinous compoundA substance used to reconstitute cranial bone after neurosurgery (i.e., cranioplasty). It typically consists of a self-curing resin [e.g., polymethylmethacrylate (PMMA)] or a two part resinous material made of several compositions. It may be conformed as an inert implant in an appropriate shape (e.g., a plate) needed to repair the defect of the skull, either using an intraoperatively cured solid composition, or a preoperatively fabricated, porous, custom-made, implant. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
070659539
Device count
1
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00855113008722ClearFit1717382024-03-20
00855113008005ClearFit1717101717102018-11-21
00855113008012ClearFit1717111717112018-11-21
00855113008029ClearFit1717121717122018-11-21
00855113008036ClearFit1717131717132018-11-21
00855113008043ClearFit1717141717142018-11-21
00855113008166ClearFit9917102024-11-20
00855113008173ClearFit9917112024-11-20
00855113008197ClearFit9917132024-11-20
00855113008746ClearFit9917122024-11-20
00855113008579ClearFit Posterior Fossa Plate1717312025-02-19
00855113008586ClearFit Retrosigmoid Large1717342025-02-19
00855113008753ClearFit Retrosigmoid Small1717332025-02-19
00860003416303ClearFit VDI Standard1717162025-02-19
00860003416310ClearFit VDI Large1717182025-02-19
00855113008739ClearFit9917142024-11-20
00855113008715ClearFit1717372024-03-20
00855113008562ClearFit1717172024-03-15
00855113008623ClearFit1717192024-03-15
00855113008630Longeviti Convenience Kit 2.07000722024-03-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810188324689HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-06-03
00810188324665HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-06-01
00810188324641HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-05-28
00810188324658HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-05-28
00810188324634HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-05-27
08859751210556METICULY Patient-specific titanium mesh implantMETICULY COMPANY LIMITEDGXN2026-03-05
08859751210563METICULY Patient-specific titanium mesh implantMETICULY COMPANY LIMITEDGXN2026-03-05
08859751210570METICULY Patient-specific titanium mesh implantMETICULY COMPANY LIMITEDGXN2026-03-05
08859751216206METICULY Patient-specific titanium mesh implantMETICULY COMPANY LIMITEDGXN2026-03-05
08859751216312METICULY Patient-specific titanium mesh implantMETICULY COMPANY LIMITEDGXN2026-03-05
08859751216329METICULY Patient-specific titanium mesh implantMETICULY COMPANY LIMITEDGXN2026-03-05
08859751216336METICULY Patient-specific titanium mesh implantMETICULY COMPANY LIMITEDGXN2026-03-05
08859751216343METICULY Patient-specific titanium mesh implantMETICULY COMPANY LIMITEDGXN2026-03-05
08859751216411METICULY Patient-specific titanium mesh implantMETICULY COMPANY LIMITEDGXN2026-03-05
08859751216428METICULY Patient-specific titanium mesh implantMETICULY COMPANY LIMITEDGXN2026-03-05
08859751216435METICULY Patient-specific titanium mesh implantMETICULY COMPANY LIMITEDGXN2026-03-05
08859751216442METICULY Patient-specific titanium mesh implantMETICULY COMPANY LIMITEDGXN2026-03-05
00810007631271AccuShapeMedcadGXN2023-06-23
00810007631288AccuShapeMedcadGXN2023-06-23
00810007631295AccuShapeMedcadGXN2023-06-23
00810077248829HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2023-01-16
00810077248836HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2023-01-16
00810077248973HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2023-01-09
00810077248980HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2023-01-05
00810077248775HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2023-01-03
00810077248706HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2022-12-21
00810077248850HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2022-12-21
00810077248904HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2022-12-21
00810077248911HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2022-12-21
00810077248928HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2022-12-21