Htr-Pekk

FDA UDI

Class II (US FDA UDI)

by Oxford Performance Materials

Identity

Trade Name: HTR-PEKK FDA UDI
Generic Name: Custom-made cranial bone prosthesis FDA UDI
Model / Reference: PK626586-A FDA UDI

Identifiers

Primary DI / UDI-DI: 00810128536691 FDA UDI
510(k) Number: K180064 FDA UDI
FDA Product Code: GXN FDA UDI
GMDN Term: Custom-made cranial bone prosthesis FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.5330 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Safe FDA UDI

Category: Custom-made cranial bone prosthesis

The HTR-PEKK custom-made cranial bone prosthesis is a cutting-edge medical device designed for patients requiring a precise and customized solution for their cranioplasty needs. This implantable device is constructed from high-quality materials such as ultrahigh molecular weight polyethylene (UHMWPE) or polyetheretherketone (PEEK), making it ideal for repairs due to injury, tumor removal, congenital anomaly, or disease. With its unique combination of design and material properties, the HTR-PEKK offers a safe and effective solution for patients seeking a replacement option.

Similar devices

Also classified as Custom-made cranial bone prosthesis.

IPS — KLS-Martin L.P. · Class II
IPS — KLS-Martin L.P. · Class II
IPS — KLS-Martin L.P. · Class II
IPS — KLS-Martin L.P. · Class II
HTR-PEKK — Oxford Performance Materials · Class II
HTR-PEKK — Oxford Performance Materials · Class II
HTR-PEKK — Oxford Performance Materials · Class II
HTR-PEKK — Oxford Performance Materials · Class II

Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Oxford Performance Materials

Sources (1)

FDA UDI 8321f7b9-63e1-44da-a6da-c8e513a2140b 34 fields · synced Jul 11, 2026