FDA.reportPublic FDA data

StarPore

Primary DI
09349797002561
Brand
StarPore
Company
ANATOMICS PTY LTD
Model
CI-STARPORE-XL2
Catalog number
CI-STARPORE-XL2
Device description
StarPore Patient Specific Implant (X-Large)
Published
2020-04-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GWOPlate, Cranioplasty, Preformed, Alterable
JOFPolymer, Ent Synthetic, Porous Polyethylene

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWOPlate, Cranioplasty, Preformed, AlterableNeurology2
JOFPolymer, Ent Synthetic, Porous PolyethyleneEar, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171037000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171037000PoreStar Patient Specific ImplantAnatomics Pty, Ltd.2017-12-27JOF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09349797002561PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09349797002561093497970025619349797002561

GMDN Terms#

Term, Definition table
TermDefinition
Polyethylene craniofacial tissue reconstructive materialA sterile implantable device intended to support, contour, and provide structure for the craniofacial anatomy (i.e., head and face including the chin, cheeks, nose, eye sockets and ears) during reconstructive and plastic surgery procedures. It is typically a high-density polyethylene (PE) material with an interconnecting pore structure that supports tissue ingrowth. The device is available in blocks, sheets, wedges and spheres that can be cut by the surgeon to meet the patient's specific needs. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+61395298088contact@anatomics.com

Regulatory Flags#

DUNS number
755739307
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09349797001366Surgical BioModelBM-IMPLANTBM-IMPLANT2020-01-08
09349797000093Surgical TemplateTP-BRTTP-BRT2020-11-26
09349797002530StarPoreCI-STARPORE-S2CI-STARPORE-S22020-04-03
09349797002547StarPoreCI-STARPORE-M2CI-STARPORE-M22020-04-03
09349797002554StarPoreCI-STARPORE-L2CI-STARPORE-L22020-04-03
09349797001700StarPoreCI-STARPORE-OTCI-STARPORE-OT2020-02-17
09349797002387StarPoreCI-STARPORE-SAMPLECI-STARPORE-SAMPLE2020-02-10
09349797000192StarPoreCI-STARPORE-SCI-STARPORE-S2020-01-08
09349797000208StarPoreCI-STARPORE-MCI-STARPORE-M2020-01-08
09349797000215StarPoreCI-STARPORE-LCI-STARPORE-L2020-01-08
09349797000222StarPoreCI-STARPORE-XLCI-STARPORE-XL2020-01-08
09349797000239StarPoreCI-STARPORE-OCI-STARPORE-O2020-01-08

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Primary DI, Brand, Company table
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