FDA.reportPublic FDA data

ST Temporalis

Primary DI
00866453000147
Brand
ST Temporalis
Company
Osteosymbionics, LLC
Model
STT-60
Device description
Silicone Temporal Implant - Large
Published
2015-10-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MNFImplant, Temporal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNFImplant, TemporalGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K111069000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111069000OSTEOSYMBIONICS, ST TEMPORALIS IMPLANTOsteosymbionics, LLC2011-09-22MNF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00866453000147PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00866453000147008664530001478664530001470866453000147

GMDN Terms#

Term, Definition table
TermDefinition
Chin prosthesisA sterile device implanted in the soft tissue of the chin to correct chin deformities or improve facial appearance. It is usually made of a polymer material.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
858769651
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00866453000109ClearShield (Non-Sterile)IMP2015-10-26
00866453000123PK ShieldIMP-PK2015-10-26
00866453000130ST TemporalisSTT-502015-10-26
00866453000116ClearShield (Sterile)SIMP2015-10-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00866453000130ST TemporalisOsteosymbionics, LLCMNF2015-10-26
07613252086451MEDPORStryker Leibinger GmbH & Co. KGMNF2015-09-24
07613252086468MEDPORStryker Leibinger GmbH & Co. KGMNF2015-09-24
07613252508526MEDPORStryker Leibinger GmbH & Co. KGMNF2015-09-24
07613252508670MEDPORStryker Leibinger GmbH & Co. KGMNF2015-09-24