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StarPore

FDA UDI

Class II (US FDA UDI)

by Anatomics Pty Ltd

Identity

Trade Name
StarPore FDA UDI
Generic Name
Polyethylene craniofacial tissue reconstructive material FDA UDI
Device Name
StarPore Patient Specific Implant (Medium) FDA UDI
Model / Reference
CI-STARPORE-M2 FDA UDI
Description
StarPore Patient Specific Implant (Medium) FDA UDI

Identifiers

Catalog Number
CI-STARPORE-M2 FDA UDI
Primary DI / UDI-DI
09349797002547 FDA UDI
510(k) Number
K171037 FDA UDI
FDA Product Code
JOF FDA UDI
GWO FDA UDI
GMDN Term
Polyethylene craniofacial tissue reconstructive material FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
874.3620 FDA UDI
882.5320 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Safe FDA UDI

Category: Polyethylene craniofacial tissue reconstructive material

StarPore by Anatomics Pty Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Polyethylene craniofacial tissue reconstructive material.

Cleared under the same submission

K171037 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Anatomics Pty Ltd

Sources (1)

  • FDA UDI 9b1fe56a-cd94-4a17-b473-f4befbfbb69e 36 fields · synced Jun 8, 2026