FDA.reportPublic FDA data

StarPore

Primary DI
09349797001700
Brand
StarPore
Company
ANATOMICS PTY LTD
Model
CI-STARPORE-OT
Catalog number
CI-STARPORE-OT
Device description
StarPore Patient Specific Implant
Published
2020-02-17
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
09349797001700PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09349797001700093497970017009349797001700

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
09349797002561StarPoreCI-STARPORE-XL2CI-STARPORE-XL22020-04-03
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800089428151Leforte Neuro System Bone PlateJeil Medical CorporationGWO2026-11-04
08806390889100Leforte Neuro System Bone PlateJeil Medical CorporationGWO2026-11-04
08806390889087Leforte Neuro System Bone PlateJeil Medical CorporationGWO2026-11-01
00810228570649FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-10-28
00810228570656FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-10-28
00810228570663CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-10-28
00810228570618FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-10-22
00810228570625FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-10-22
00810228570632CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-10-22
00810228570571CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-10-15
00810228570588CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-10-15
00810228570595CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-10-15
00810228570601FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-10-15
00810228570540CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-10-07
00810228570557CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-10-07
00810228570564CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-10-07
00810228570519CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-10-01
00810228570526FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-10-01
00810228570533CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-10-01
00810228570465FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-09-28
00810228570472CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-09-28
00810228570489CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-09-28
00810228570496FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-09-28
00810228570502FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-09-28
00810228570458CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-09-21
00810228570373CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-09-18
00810228570380CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-09-18
00810228570397FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-09-18
00810228570403CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-09-18
00810228570410FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-09-18