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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
PK620165-A FDA UDI

Identifiers

Primary DI / UDI-DI
00810042031531 FDA UDI
510(k) Number
K161052 FDA UDI
FDA Product Code
KKY FDA UDI
GMDN Term
Custom-made cranial bone prosthesis FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.3500 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

Htr-Pekk by Oxford Performance Materials — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Custom-made cranial bone prosthesis.

Cleared under the same submission

K161052 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 ee1ae98f-a272-4957-a69f-a0cc70d609d1 34 fields · synced May 30, 2026