FDA.report

Spectrum Designs Medical

Primary DI
B018S130314S1
Brand
Spectrum Designs Medical
Company
SPECTRUM DESIGNS INC
Model
Anatomical Malar II, size 1
Catalog number
S130-314S
Published
2015-10-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
LZKImplant, Malar

Product Code Classifications

CodeDeviceSpecialtyClass
LZKImplant, MalarGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B018S130314S1PrimaryHIBCC0

GMDN Terms

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

Contacts

PhoneEmail
8056847678service@spectrumdesignsmedical

Regulatory Flags

DUNS number
148681521
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
B018550111LT1Spectrum Designs MedicalPectoral 1, Aiache, Left, Size 1550-111LT2015-10-23
B018550111RT1Spectrum Designs MedicalPectoral 1, Aiache, Right, Size 1550-111RT2015-10-23
B018550121LT1Spectrum Designs MedicalPectoral 1, Aiache, Left, Size 2550-121LT2015-10-23
B018550121RT1Spectrum Designs MedicalPectoral 1, Aiache, Right, Size 2550-121RT2015-10-23
B018550131LT1Spectrum Designs MedicalPectoral 1, Aiache, Left, Size 3550-131LT2015-10-23
B018550131RT1Spectrum Designs MedicalPectoral 1, Aiache, Right, Size 3550-131RT2015-10-23
B018550141LT1Spectrum Designs MedicalPectoral 1, Aiache, Left, Size 4550-141LT2015-10-23
B018550141RT1Spectrum Designs MedicalPectoral 1, Aiache, Right, Size 4550-141RT2015-10-23
B018550411LT1Spectrum Designs MedicalPectoral 2, Novack, Left550-411LT2015-10-23
B018550411RT1Spectrum Designs MedicalPectoral 2, Novack, Right550-411RT2015-10-23
B018550511LT1Spectrum Designs MedicalPectoral 3, Novack, Left550-511LT2015-10-23
B018550511RT1Spectrum Designs MedicalPectoral 3, Novack, Right550-511RT2015-10-23
B018550611LT1Spectrum Designs MedicalPectoral 4, Aiache, Left, Size 1550-611LT2015-10-23
B018550611RT1Spectrum Designs MedicalPectoral 4, Aiache, Right, Size 1550-611RT2015-10-23
B018550621LT1Spectrum Designs MedicalPectoral 4, Aiache, Left, Size 2550-621LT2015-10-23
B018550621RT1Spectrum Designs MedicalPectoral 4, Aiache, Right, Size 2550-621RT2015-10-23
B018550631LT1Spectrum Designs MedicalPectoral 4, Aiache, Left, Size 3550-631LT2015-10-23
B018550631RT1Spectrum Designs MedicalPectoral 4, Aiache, Right, Size 3550-631RT2015-10-23
B018120214S1Spectrum Designs MedicalAnatomical Malar I, size 1120-214S2015-10-23
B018120224S1Spectrum Designs MedicalAnatomical Malar I, size 2120-224S2015-10-23

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Primary DIBrandCompanyProduct codePublished
B4904011015Malar ImplantAartLZK2025-08-28
B4904011016Malar ImplantAartLZK2025-08-28
B4904011025Malar ImplantAartLZK2025-08-28
B4904011026Malar ImplantAartLZK2025-08-28
B4904011035Malar ImplantAartLZK2025-08-28
B4904011036Malar ImplantAartLZK2025-08-28
B4904012015Malar ImplantAartLZK2025-08-28
B4904012016Malar ImplantAartLZK2025-08-28
B4904012025Malar ImplantAartLZK2025-08-28
B4904012026Malar ImplantAartLZK2025-08-28
M724ESPF501Solid ePTFE Paranasal, Flat TopIMPLANTECH ASSOCIATES, INC.LZK2024-11-01
M724ESPF701Solid ePTFE Paranasal, Flat TopIMPLANTECH ASSOCIATES, INC.LZK2024-11-01
M724ESPS501Solid ePTFE Paranasal, Sharp TopIMPLANTECH ASSOCIATES, INC.LZK2024-11-01
00888233043717HTR-PMIBIOMET MICROFIXATION, INCLZK2021-07-28
00888233043786HTR-PMIBIOMET MICROFIXATION, INCLZK2021-07-28
00888233043793HTR-PMIBIOMET MICROFIXATION, INCLZK2021-07-28
00888233044271HTR-PMIBIOMET MICROFIXATION, INCLZK2021-07-28
00888233044288HTR-PMIBIOMET MICROFIXATION, INCLZK2021-07-28
00888233044295HTR-PMIBIOMET MICROFIXATION, INCLZK2021-07-28
M7249000101900-010 Anatomical Malar I Sizer SetIMPLANTECH ASSOCIATES, INC.LZK2021-07-20
M7249000111900-011 Anatomical Malar II Sizer SetIMPLANTECH ASSOCIATES, INC.LZK2021-07-20
M7249000121900-012 Extended Malar Sizer SetIMPLANTECH ASSOCIATES, INC.LZK2021-07-20
M7249000131900-013 Combined Malar Sizer SetIMPLANTECH ASSOCIATES, INC.LZK2021-07-20
M724120214S1Anatomical Malar IIMPLANTECH ASSOCIATES, INC.LZK2021-04-13
M724120224S1Anatomical Malar IIMPLANTECH ASSOCIATES, INC.LZK2021-04-13
M724120234S1Anatomical Malar IIMPLANTECH ASSOCIATES, INC.LZK2021-04-13
M724130314S1Anatomical Malar IIIMPLANTECH ASSOCIATES, INC.LZK2021-04-13
M724130324S1Anatomical Malar IIIMPLANTECH ASSOCIATES, INC.LZK2021-04-13
M724130334S1Anatomical Malar IIIMPLANTECH ASSOCIATES, INC.LZK2021-04-13
M724140414S1Profile MalarIMPLANTECH ASSOCIATES, INC.LZK2021-04-13