FDA.report

HTR-PEKK

Primary DI
00810188324627
Brand
HTR-PEKK
Company
OXFORD PERFORMANCE MATERIALS, INC.
Model
PK627332
Published
2026-05-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
GXNPlate, Cranioplasty, Preformed, Non-Alterable

Product Code Classifications

CodeDeviceSpecialtyClass
GXNPlate, Cranioplasty, Preformed, Non-AlterableNeurology2

Premarket Submissions

SubmissionSupplement
K180064000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K180064000OsteoFab Patient Specific Cranial DeviceOxford Performance Materials, Inc.2018-07-27GXN

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810188324627PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810188324627008101883246278101883246270810188324627

GMDN Terms

TermDefinition
Custom-made cranial bone prosthesisAn 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
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
904-741-4400fxjax-orders@biomet.com

Regulatory Flags

DUNS number
962301359
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00810188324511HTR-PEKKPK6273202026-05-26
00810188324603HTR-PEKKPK627324-A2026-05-26
00810188324573HTR-PEKKPK6273292026-05-22
00810188324597HTR-PEKKPK6273282026-05-22
00810188323767HTR-PEKKPK6272532026-03-24
00810188323866HTR-PEKKPK6272372026-03-24
00810188323873HTR-PEKKPK6272602026-03-24
00810188323552HTR-PEKKPK6272312026-03-23
00810188323859HTR-PEKKPK6272592026-03-23
00810188323828HTR-PEKKPK6272562026-03-20
00810188323811HTR-PEKKPK6272552026-03-19
00810188323835HTR-PEKKPK6272572026-03-19
00810188323750HTR-PEKKPK6272522026-03-17
00810188323712HTR-PEKKPK6272482026-03-13
00810188323736HTR-PEKKPK6272502026-03-13
00810188323743HTR-PEKKPK6272512026-03-13
00810188323699HTR-PEKKPK6272402026-03-12
00810188323705HTR-PEKKPK6272432026-03-12
00810188323620HTR-PEKKPK6272382026-03-10
00810188323668HTR-PEKKPK6272462026-03-10

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00810188324511HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-05-26
00810188324603HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-05-26
00810188324573HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-05-22
00810188324597HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-05-22
00810188323767HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-03-24
00810188323866HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-03-24
00810188323873HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-03-24
00810125929274KELYNIAM CSIKELYNIAM GLOBAL, INC.GXN2026-03-23
00810125929281KELYNIAM CSIKELYNIAM GLOBAL, INC.GXN2026-03-23
00810188323552HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-03-23
00810188323859HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-03-23
00810125929229KELYNIAM CSIKELYNIAM GLOBAL, INC.GXN2026-03-20
00810125929236KELYNIAM CSIKELYNIAM GLOBAL, INC.GXN2026-03-20
00810125929243KELYNIAM CSIKELYNIAM GLOBAL, INC.GXN2026-03-20
00810125929250KELYNIAM CSIKELYNIAM GLOBAL, INC.GXN2026-03-20
00810125929267KELYNIAM CSIKELYNIAM GLOBAL, INC.GXN2026-03-20
00810188323828HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-03-20
00810188323811HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-03-19
00810188323835HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-03-19
00810188323750HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-03-17
00810125929168KELYNIAM CSIKELYNIAM GLOBAL, INC.GXN2026-03-16
00810125929175KELYNIAM CSIKELYNIAM GLOBAL, INC.GXN2026-03-16
00810125929182KELYNIAM CSIKELYNIAM GLOBAL, INC.GXN2026-03-16
00810125929199KELYNIAM CSIKELYNIAM GLOBAL, INC.GXN2026-03-16
00810125929205KELYNIAM CSIKELYNIAM GLOBAL, INC.GXN2026-03-16
00810125929212KELYNIAM CSIKELYNIAM GLOBAL, INC.GXN2026-03-16
00810188323712HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-03-13
00810188323736HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-03-13
00810188323743HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-03-13
00810188323699HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-03-12