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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
PK624216 FDA UDI

Identifiers

Primary DI / UDI-DI
00810077240212 FDA UDI
510(k) Number
K121818 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

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

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 device is a custom-made cranial bone prosthesis designed for repair and reconstruction of defects in the cranium or mandible. Made from high-quality ultrahigh molecular weight polyethylene (UHMWPE) or polyetheretherketone (PEEK), this implantable device is constructed based on computed tomography (CT) images and provides a safe and effective solution for patients seeking a reliable repair.

Similar devices

Also classified as Custom-made cranial bone prosthesis.

Cleared under the same submission

K121818 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Oxford Performance Materials

Sources (1)

  • FDA UDI c4afafec-930c-484f-9eb6-33a390023591 34 fields · synced Jun 20, 2026