FDA.reportPublic FDA data

Malar Implant

Primary DI
B049SM210
Brand
Malar Implant
Company
Hanson Medical, Inc.
Model
SM 2-1
Catalog number
SM 2-1
Device description
Sterile, silicone, malar implant, pair.
Published
2015-10-08
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
LZKImplant, Malar

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K090803000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K090803000HANSON MEDICAL FACIAL IMPLANTSHanson Medical, Inc.2010-06-30FZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B049SM210PrimaryHIBCC0

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
1(800)771-2215erik@hansonmedical.com

Regulatory Flags#

DUNS number
058759296
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
B049N101F0Nasal ImplantN 10-1 FN 10-1 F2015-10-07
B049N101S0Nasal ImplantN 10-1 SN 10-1 S2015-10-07
B049N101W0Nasal ImplantN 10-1 WN 10-1 W2015-10-07
B049N102F0Nasal ImplantN 10-2 FN 10-2 F2015-10-07
B049N102S0Nasal ImplantN 10-2 SN 10-2 S2015-10-07
B049N102W0Nasal ImplantN 10-2 WN 10-2 W2015-10-07
B049N11F0Nasal ImplantN - 11 FN - 11 F2015-10-07
B049N11S0Nasal ImplantN - 11 SN - 11 S2015-10-07
B049N11W0Nasal ImplantN - 11 WN - 11 W2015-10-07
B049N121F0Nasal ImplantN 12-1 FN 12-1 F2015-10-07
B049N121S0Nasal ImplantN 12-1 SN 12-1 S2015-10-07
B049N121W0Nasal ImplantN 12-1 WN 12-1 W2015-10-07
B049N122F0Nasal ImplantN 12-2 FN 12-2 F2015-10-07
B049N122S0Nasal ImplantN 12-2 SN 12-2 S2015-10-07
B049N122W0Nasal ImplantN 12-2 WN 12-2 W2015-10-07
B049N131F0Nasal ImplantN 13-1 FN 13-1 F2015-10-07
B049N131S0Nasal ImplantN 13-1 SN 13-1 S2015-10-07
B049N132F0Nasal ImplantN 13-2 FN 13-2 F2015-10-07
B049N132S0Nasal ImplantN 13-2 SN 13-2 S2015-10-07
B049N133F0Nasal ImplantN 13-3 FN 13-3 F2015-10-07

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