FDA.reportPublic FDA data

Spectrum Designs Medical

Primary DI
B018S150514S1
Brand
Spectrum Designs Medical
Company
SPECTRUM DESIGNS INC
Model
Extended Malar, size 1
Catalog number
S150-514S
Published
2015-10-23
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
LZKImplant, Malar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZKImplant, MalarGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B018S150514S1PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Malar prosthesisAn implantable device designed to augment or maintain the soft-tissue anatomy of the malar area (cheek). The device is typically a solid elastomer (e.g., silicone) available in several shapes and sizes for subdermal implantation in the malar area for cosmetic or reconstructive purposes following traumatic or disease/congenital deformation. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8056847678service@spectrumdesignsmedical

Regulatory Flags#

DUNS number
148681521
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B018400114S1Spectrum Designs MedicalDorsal Columella, Style 1400-114S2015-10-23
B018400214S1Spectrum Designs MedicalDorsal Columella, Style 2400-214S2015-10-23
B018400314S1Spectrum Designs MedicalDorsal Columella, Style 3400-314S2015-10-23
B018400414S1Spectrum Designs MedicalDorsal Columella, Style 4400-414S2015-10-23
B018400514S1Spectrum Designs MedicalDorsal Columella, Style 5, size 1400-514S2015-10-23
B018400524S1Spectrum Designs MedicalDorsal Columella, Style 5, size 2400-524S2015-10-23
B018400534S1Spectrum Designs MedicalDorsal Columella, Style 5, size 3400-534S2015-10-23
B018400544S1Spectrum Designs MedicalDorsal Columella, Style 5, size 4400-544S2015-10-23
B018400614S1Spectrum Designs MedicalVoloshin Dorsal Columella, size 1400-614S2015-10-23
B018400624S1Spectrum Designs MedicalVoloshin Dorsal Columella, size 2400-624S2015-10-23
B018400634S1Spectrum Designs MedicalVoloshin Dorsal Columella, size 3400-634S2015-10-23
B018400644S1Spectrum Designs MedicalVoloshin Dorsal Columella, size 4400-644S2015-10-23
B018400654S1Spectrum Designs MedicalVoloshin Dorsal Columella, size 5400-654S2015-10-23
B018400664S1Spectrum Designs MedicalVoloshin Dorsal Columella, size 6400-664S2015-10-23
B018400714S1Spectrum Designs MedicalNasal Dorsum Style 7, size 1400-714S2015-10-23
B018400724S1Spectrum Designs MedicalNasal Dorsum Style 7, size 2400-724S2015-10-23
B018400734S1Spectrum Designs MedicalNasal Dorsum Style 7, size 3400-734S2015-10-23
B018400744S1Spectrum Designs MedicalNasal Dorsum Style 7, size 4400-744S2015-10-23
B018400754S1Spectrum Designs MedicalNasal Dorsum Style 7, size 5400-754S2015-10-23
B018400814S1Spectrum Designs MedicalNasal Dorsum Style 8, size 1400-814S2015-10-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M724BSMIISIZNS1Binder Submalar® II SizerIMPLANTECH ASSOCIATES, INC.LZK2017-10-17
M724BSMSIZNS1Binder Submalar® SizerIMPLANTECH ASSOCIATES, INC.LZK2017-10-17
M724CBSMSIZNS1Conform Binder Submalar® SizersIMPLANTECH ASSOCIATES, INC.LZK2017-10-17
M724CCSMSIZNS1Conform Midfacial Implant SizersIMPLANTECH ASSOCIATES, INC.LZK2017-10-17
M724CMASIZNS1Conform Mandibular Angle™ SizersIMPLANTECH ASSOCIATES, INC.LZK2017-10-17
M724CSMSIZNS1Combined Submalar Shell™ SizersIMPLANTECH ASSOCIATES, INC.LZK2017-10-17
M724CTMSSIZNS1Conform Terino Malar Shell® IMPLANTECH ASSOCIATES, INC.LZK2017-10-17
M724FTTSIZNS1Flowers Tear Trough® SizersIMPLANTECH ASSOCIATES, INC.LZK2017-10-17
M724TMSSIZNS1Terino Malar Shell® SizersIMPLANTECH ASSOCIATES, INC.LZK2017-10-17
00841036204181HTR-PMIBIOMET MICROFIXATION, INCLZK2015-12-15
00841036204198HTR-PMIBIOMET MICROFIXATION, INCLZK2015-12-15
00841036204204HTR-PMIBIOMET MICROFIXATION, INCLZK2015-12-15
00841036204211HTR-PMIBIOMET MICROFIXATION, INCLZK2015-12-15
00841036204228HTR-PMIBIOMET MICROFIXATION, INCLZK2015-12-15
00841036204235HTR-PMIBIOMET MICROFIXATION, INCLZK2015-12-15
00841036204242HTR-PMIBIOMET MICROFIXATION, INCLZK2015-12-15
00841036204259HTR-PMIBIOMET MICROFIXATION, INCLZK2015-12-15
00841036204273HTR-PMIBIOMET MICROFIXATION, INCLZK2015-12-15
00841036204280HTR-PMIBIOMET MICROFIXATION, INCLZK2015-12-15
00841036203955HTR-PMIBIOMET MICROFIXATION, INCLZK2015-12-14
00841036203979HTR-PMIBIOMET MICROFIXATION, INCLZK2015-12-14
00841036203856HTR-PMIBIOMET MICROFIXATION, INCLZK2015-12-09
00841036203788HTR-PMIBIOMET MICROFIXATION, INCLZK2015-12-08
00841036203795HTR-PMIBIOMET MICROFIXATION, INCLZK2015-12-08
00841036203801HTR-PMIBIOMET MICROFIXATION, INCLZK2015-12-08
00841036203580HTR-PMIBIOMET MICROFIXATION, INCLZK2015-12-07
00841036203610HTR-PMIBIOMET MICROFIXATION, INCLZK2015-12-07
00841036203627HTR-PMIBIOMET MICROFIXATION, INCLZK2015-12-07
00841036203351HTR-PMIBIOMET MICROFIXATION, INCLZK2015-12-04
00841036203368HTR-PMIBIOMET MICROFIXATION, INCLZK2015-12-04