FDA.reportPublic FDA data

Chin Implant

Primary DI
B049VCH2S0
Brand
Chin Implant
Company
Hanson Medical, Inc.
Model
VCH - 2 S
Catalog number
VCH - 2 S
Device description
Non-sterile, silicone, chin implant, sizer.
Published
2015-09-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FWPProsthesis, Chin, Internal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FWPProsthesis, Chin, InternalGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K973575000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K973575000DURALASTIC ANATOMICAL CHIN IMPLANTSHanson Medical, Inc.1997-11-07FWP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B049VCH2S0PrimaryHIBCC0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
1(800)771-2215erik@hansonmedical.com

Regulatory Flags#

DUNS number
058759296
Device count
1
Lot or batch
true
Sterilization required before use
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
07613327300536MEDPORStryker Leibinger GmbH & Co. KGFWP2023-02-13
07613327300406MEDPORStryker Leibinger GmbH & Co. KGFWP2023-01-09
07613327300413MEDPORStryker Leibinger GmbH & Co. KGFWP2023-01-09
07613327300437MEDPORStryker Leibinger GmbH & Co. KGFWP2023-01-09
07613327300444MEDPORStryker Leibinger GmbH & Co. KGFWP2023-01-09
07613327300451MEDPORStryker Leibinger GmbH & Co. KGFWP2023-01-09
07613327300475MEDPORStryker Leibinger GmbH & Co. KGFWP2023-01-09
07613327300499MEDPORStryker Leibinger GmbH & Co. KGFWP2023-01-09
07613327300505MEDPORStryker Leibinger GmbH & Co. KGFWP2023-01-09
07613327300512MEDPORStryker Leibinger GmbH & Co. KGFWP2023-01-09
07613327300529MEDPORStryker Leibinger GmbH & Co. KGFWP2023-01-09
07613327300550MEDPORStryker Leibinger GmbH & Co. KGFWP2023-01-09
07613327300567MEDPORStryker Leibinger GmbH & Co. KGFWP2023-01-09
00815285022766Su-Por Surgical ImplantPORIFEROUS, LLCFWP2020-03-25
00815285022773Su-Por Surgical ImplantPORIFEROUS, LLCFWP2020-03-25
00815285022780Su-Por Surgical ImplantPORIFEROUS, LLCFWP2020-03-25
00815285022797Su-Por Surgical ImplantPORIFEROUS, LLCFWP2020-03-25
07613327480245MEDPORStryker Leibinger GmbH & Co. KGFWP2019-09-20
M724VMA11LNS1Vertical Mandibular Angle™IMPLANTECH ASSOCIATES, INC.FWP2019-05-15
M724VMA11RNS1Vertical Mandibular Angle™IMPLANTECH ASSOCIATES, INC.FWP2019-05-15
M724VMA13LNS1Vertical Mandibular Angle™IMPLANTECH ASSOCIATES, INC.FWP2019-05-15
M724VMA13RNS1Vertical Mandibular Angle™IMPLANTECH ASSOCIATES, INC.FWP2019-05-15
M724VMA7LNS1Vertical Mandibular Angle™IMPLANTECH ASSOCIATES, INC.FWP2019-05-15
M724VMA7RNS1Vertical Mandibular Angle™IMPLANTECH ASSOCIATES, INC.FWP2019-05-15
M724ACSIZNS1Anatomical Chin SizersIMPLANTECH ASSOCIATES, INC.FWP2017-10-17
M724CEACSIZNS1Conform™ Extended AnatomicalIMPLANTECH ASSOCIATES, INC.FWP2017-10-17
M724CSCSIZNS1Curvilinear Silicone Chin SizersIMPLANTECH ASSOCIATES, INC.FWP2017-10-17
M724EACSIZNS1Extended Anatomical Chin SizersIMPLANTECH ASSOCIATES, INC.FWP2017-10-17
M724FMGVSIZNS1Flowers Mandibular Glove® Sizers IMPLANTECH ASSOCIATES, INC.FWP2017-10-17
M724MPJSIZNS1Mandibular Pre Jowl® ImplantIMPLANTECH ASSOCIATES, INC.FWP2017-10-17