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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
PK620012 FDA UDI

Identifiers

Primary DI / UDI-DI
00810042030114 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

Category: Custom-made cranial bone prosthesis

Improve your patient's cranium with the HTR-PEKK custom-made cranial bone prosthesis, designed and manufactured by Oxford Performance Materials, Inc. This non-invasive device is intended for single-use applications, making it a safe choice for patients seeking alternative treatments.

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 0f8d9526-643d-4f46-89a1-27dcb2c36463 34 fields · synced Jul 20, 2026