FDA.reportPublic FDA data

ClearFit Ti Ring

Primary DI
00855113008814
Brand
ClearFit Ti Ring
Company
LONGEVITI NEURO SOLUTIONS LLC
Model
171754
Published
2026-10-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GXNPlate, Cranioplasty, Preformed, Non-Alterable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXNPlate, Cranioplasty, Preformed, Non-AlterableNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K260709000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K260709000ClearFit Ti Ring 14mm (171750);ClearFit Ti Ring 14mm with Slot (171751);ClearFit Ti Ring 20mm (171752);ClearFit Ti Ring 20mm with Slot (171753);ClearFit Ti Ring 30mm (171754)Longeviti Neuro Solutions2026-06-25GXN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00855113008814PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00855113008814008551130088148551130088140855113008814

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.

Regulatory Flags#

DUNS number
070659539
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00855113008777ClearFit Ti Ring1717502026-10-26
00855113008784ClearFit Ti Ring1717512026-10-26
00855113008791ClearFit Ti Ring1717522026-10-26
00855113008807ClearFit Ti Ring1717532026-10-26
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810188325983HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-10-26
00855113008777ClearFit Ti RingLONGEVITI NEURO SOLUTIONS LLCGXN2026-10-26
00855113008784ClearFit Ti RingLONGEVITI NEURO SOLUTIONS LLCGXN2026-10-26
00855113008791ClearFit Ti RingLONGEVITI NEURO SOLUTIONS LLCGXN2026-10-26
00855113008807ClearFit Ti RingLONGEVITI NEURO SOLUTIONS LLCGXN2026-10-26
00810188325662HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-10-22
00810188325952HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-10-21
00810188325969HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-10-21
00810188325976HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-10-21
00810188325839HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-10-20
00810188325914HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-10-20
00810188325938HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-10-20
00810188325945HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-10-19
00810188325884HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-10-14
00810188325891HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-10-14
00810188325853HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-10-13
00810188325563HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-10-12
00810188325815HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-10-12
00810188325860HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-10-12
00810188325877HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-10-12
00810188325846HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-10-09
00810188325785HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-10-08
00810188324801HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-10-07
00810188325761HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-10-07
00810188325617HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-10-06
00810188325778HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-10-06
00810188325716HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-10-05
00810188325792HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-10-05
00810188325808HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-10-05
00810188325709HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-09-30