FDA.reportPublic FDA data

HTR-PEKK

Primary DI
00810023920854
Brand
HTR-PEKK
Company
OXFORD PERFORMANCE MATERIALS, INC.
Model
PK622295
Published
2019-08-15
Public version status
Update
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
K121818000
K161052000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121818000OSTEOFAB PATIENT SPECIFIC CRANIAL DEVICEOxford Performance Materials2013-02-07GXN
K161052000OsteoFab Patient Specific Facial DeviceOxford Performance Materials, Inc.2016-07-20KKY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810023920854PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810023920854008100239208548100239208540810023920854

GMDN Terms#

Term, Definition table
TermDefinition
Cranial bone prosthesis, custom-madeA sterile 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

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
00810188324634HTR-PEKKPK627331-A2026-05-27
00810188324511HTR-PEKKPK6273202026-05-26
00810188324603HTR-PEKKPK627324-A2026-05-26
00810188324627HTR-PEKKPK6273322026-05-26
00810188324573HTR-PEKKPK6273292026-05-22
00810188324597HTR-PEKKPK6273282026-05-22
00810188324214HTR-PEKKPK6272882026-05-21
00810188324429HTR-PEKKPK6273112026-05-19
00810188324320HTR-PEKKPK6273002026-05-18
00810188324559HTR-PEKKPK627291-A2026-05-18
00810188324566HTR-PEKKPK6273252026-05-18
00810188324535HTR-PEKKPK627270-A2026-05-15
00810188324542HTR-PEKKPK6273152026-05-14
00810188324528HTR-PEKKPK6273232026-05-13
00810188324405HTR-PEKKPK6273082026-05-12
00810188324412HTR-PEKKPK6273102026-05-12
00810188324504HTR-PEKKPK6273192026-05-11
00810188324450HTR-PEKKPK6273142026-05-08
00810188324474HTR-PEKKPK6273182026-05-08
00810188324481HTR-PEKKPK6273212026-05-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00810077247471HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2022-09-15
00810077247488HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2022-09-15
00810077247501HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2022-09-15
10887587073224NASynthes GmbHGXN2022-08-05
10887587073248NASynthes GmbHGXN2022-08-05
10887587074566NASynthes GmbHGXN2022-08-05
10887587074795NASynthes GmbHGXN2022-08-05
10887587074849NASynthes GmbHGXN2022-08-05
10887587075150NASynthes GmbHGXN2022-08-05
10887587075167NASynthes GmbHGXN2022-08-05
10887587073132NASynthes GmbHGXN2022-07-15
10887587073163NASynthes GmbHGXN2022-07-15
10887587073217NASynthes GmbHGXN2022-07-15
10887587073231NASynthes GmbHGXN2022-07-15