FDA.reportPublic FDA data

HTR-PEKK

Primary DI
00810188325891
Brand
HTR-PEKK
Company
OXFORD PERFORMANCE MATERIALS, INC.
Model
PK627447
Published
2026-10-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

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
K180064000

Premarket Details#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810188325891PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810188325891008101883258918101883258910810188325891

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
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 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.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
00810188325884HTR-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