FDA.reportPublic FDA data

HTR-PEKK

Primary DI
00810023920984
Brand
HTR-PEKK
Company
OXFORD PERFORMANCE MATERIALS, INC.
Model
PK622354
Published
2019-08-20
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
00810023920984PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810023920984008100239209848100239209840810023920984

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
00810188325044HTR-PEKKPK6273702026-08-03
00810188325181HTR-PEKKPK6273732026-08-03
00810188325204HTR-PEKKPK6273802026-08-03
00810188325174HTR-PEKKPK6273792026-07-31
00850004435007OsteoFab Suture AnchorINS002-02-0012020-01-16
00850004435014OsteoFab Suture AnchorINS002-01-0012020-01-16
00850004435021OsteoFab Suture AnchorINS002-01-0022020-01-16
00850004435038OsteoFab Suture AnchorINS002-01-0032020-01-16
00850004435045OsteoFab Suture AnchorSA002-452020-01-16
00850004435052OsteoFab Suture AnchorSA002-552020-01-16
00850004435069OsteoFab Suture AnchorSA002-652020-01-16
00810188325129HTR-PEKKPK6273742026-07-28
00810188325105HTR-PEKKPK6273572026-07-27
00810188325099HTR-PEKKPK627344-A2026-07-23
00810188325112HTR-PEKKPK6273722026-07-23
00810188325068HTR-PEKKPK6273712026-07-20
00810188325075HTR-PEKKPK627343-B2026-07-20
00810188325082HTR-PEKKPK627368-A2026-07-20
00810188325051HTR-PEKKPK6273272026-07-17
00810188324955HTR-PEKKPK6273592026-07-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810188325044HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-08-03
00810188325181HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-08-03
00810188325204HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-08-03
00810188325174HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-07-31
00810188325129HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-07-28
00810188325105HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-07-27
00810188325099HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-07-23
00810188325112HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-07-23
00810188325068HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-07-20
00810188325075HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-07-20
00810188325082HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-07-20
00810188325051HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-07-17
00810188324955HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-07-14
00810188325013HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-07-14
00810188324795HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-07-13
00810188324948HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-07-13
00810188324986HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-07-13
00810188324931HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-07-10
00810188324979HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-07-10
00810188324924HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-07-09
00810188324702HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-07-07
00810188324917HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-07-06
00810188324818HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-06-26
00810188324849HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-06-26
00810188324856HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-06-26
00810188324672HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-06-22
00810188324757HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-06-22
00810188324788HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-06-22
00810188324177HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-06-09
00810188324719HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-06-09