FDA.reportPublic FDA data

HTR-PEKK

Primary DI
00810128537384
Brand
HTR-PEKK
Company
OXFORD PERFORMANCE MATERIALS, INC.
Model
PK626691
Published
2024-09-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GXNPlate, Cranioplasty, Preformed, Non-Alterable
KKYMaterial, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXNPlate, Cranioplasty, Preformed, Non-AlterableNeurology2
KKYMaterial, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial ReconstructionGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K161052000
K180064000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161052000OsteoFab Patient Specific Facial DeviceOxford Performance Materials, Inc.2016-07-20KKY
K180064000OsteoFab Patient Specific Cranial DeviceOxford Performance Materials, Inc.2018-07-27GXN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810128537384PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810128537384008101285373848101285373840810128537384

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
904-741-4400fxjax-orders@biomet.com

Regulatory Flags#

DUNS number
962301359
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810188326065HTR-PEKKPK6274592026-11-05
00810188326096HTR-PEKKPK6274662026-11-05
00810188326010HTR-PEKKPK6274602026-11-04
00810188326027HTR-PEKKPK6274612026-11-03
00810188326072HTR-PEKKPK6274652026-11-03
00810188326089HTR-PEKKPK6274462026-11-04
00810188326102HTR-PEKKPK6274672026-11-04
00810188326003HTR-PEKKPK6274542026-10-30
00810188326041HTR-PEKKPK6274642026-10-30
00810188326058HTR-PEKKPK6274622026-10-30
00810188325983HTR-PEKKPK6274572026-10-26
00810188325662HTR-PEKKPK6274222026-10-22
00810188325952HTR-PEKKPK6274532026-10-21
00810188325969HTR-PEKKPK6274552026-10-21
00810188325976HTR-PEKKPK6274562026-10-21
00810188325839HTR-PEKKPK6274392026-10-20
00810188325914HTR-PEKKPK6274482026-10-20
00810188325938HTR-PEKKPK6274512026-10-20
00810188325945HTR-PEKKPK6274522026-10-19
00810188325907HTR-PEKKPK6274492026-10-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810188326065HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-11-05
00810188326096HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-11-05
00810188326010HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-11-04
00810188326089HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-11-04
00810188326102HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-11-04
00810188326027HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-11-03
00810188326072HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-11-03
00810188326003HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-10-30
00810188326041HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-10-30
00810188326058HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-10-30
00810188325983HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2026-10-26
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
00855113008814ClearFit 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
00810188325907HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2026-10-16
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