FDA.reportPublic FDA data

Hintermann Series H2

Primary DI
B095322315
Brand
Hintermann Series H2
Company
Dt Medtech, LLC
Model
322315
Catalog number
322315
Device description
H2 PE INLAY SIZE 3 LEFT 5MM/ANTERIOR
Published
2018-03-20
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HSNProsthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSNProsthesis, Ankle, Semi-Constrained, Cemented, Metal/PolymerOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B095322315PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Ankle prosthesis bearingA sterile implantable device made of polyethylene (PE) designed to articulate the tibial and talar components of a total ankle prosthesis.

Contacts#

Phone, Email table
PhoneEmail
800-521-5002quality@dtmedtech.com

Regulatory Flags#

DUNS number
080101891
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B095129681Hintermann Series1296811296812018-10-16
B095129682Hintermann Series1296821296822018-10-16
B095129696Hintermann Series1296961296962018-10-16
B095319375Hintermann Series3193753193752018-10-08
B095129680Hintermann Series1296801296802018-10-16
B095129683Hintermann Series1296831296832018-10-16
B095129684Hintermann Series1296841296842018-10-16
B095129685Hintermann Series1296851296852018-10-16
B095129686Hintermann Series1296861296862018-10-16
B095129690Hintermann Series1296901296902018-10-16
B095129691Hintermann Series1296911296912018-10-16
B095129692Hintermann Series1296921296922018-10-16
B095129693Hintermann Series1296931296932018-10-16
B095129694Hintermann Series1296941296942018-10-16
B095129695Hintermann Series1296951296952018-10-16
B095319869Hintermann Series3198693198692021-01-15
B095309630Hintermann Series3096303096302018-10-04
B095319680Hintermann Series3196803196802018-10-16
B095319681Hintermann Series3196813196812018-10-16
B095319682Hintermann Series3196823196822018-10-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840097534237Kinos Aeros Total Ankle ReplacementRestor3d, Inc.HSN2026-07-31
00840097534244Kinos Aeros Total Ankle ReplacementRestor3d, Inc.HSN2026-07-31
00840097534251Kinos Aeros Total Ankle ReplacementRestor3d, Inc.HSN2026-07-31
00840097534268Kinos Aeros Total Ankle ReplacementRestor3d, Inc.HSN2026-07-31
00840097534275Kinos Aeros Total Ankle ReplacementRestor3d, Inc.HSN2026-07-31
00840097534282Kinos Aeros Total Ankle ReplacementRestor3d, Inc.HSN2026-07-31
00889797111089PROPHECY INCOMPASSWRIGHT MEDICAL TECHNOLOGY, INC.HSN2026-06-23
00889797111096PROPHECY INCOMPASSWRIGHT MEDICAL TECHNOLOGY, INC.HSN2026-06-23
00889797111102PROPHECY INCOMPASSWRIGHT MEDICAL TECHNOLOGY, INC.HSN2026-06-23
00889797111119PROPHECY INCOMPASSWRIGHT MEDICAL TECHNOLOGY, INC.HSN2026-06-23
00889797111126PROPHECY INCOMPASSWRIGHT MEDICAL TECHNOLOGY, INC.HSN2026-06-23
00889797114820PROPHECY INCOMPASSWRIGHT MEDICAL TECHNOLOGY, INC.HSN2026-06-23
00889797114837PROPHECY INCOMPASSWRIGHT MEDICAL TECHNOLOGY, INC.HSN2026-06-23
10885862290854VantageExactech, Inc.HSN2022-07-28
B095401122Hintermann Series H2Dt Medtech, LLCHSN2018-03-21
B095402112Hintermann Series H2Dt Medtech, LLCHSN2018-03-21
B095402113Hintermann Series H2Dt Medtech, LLCHSN2018-03-21
B095402114Hintermann Series H2Dt Medtech, LLCHSN2018-03-21
B095402121Hintermann Series H2Dt Medtech, LLCHSN2018-03-21
B095402122Hintermann Series H2Dt Medtech, LLCHSN2018-03-21
B095402123Hintermann Series H2Dt Medtech, LLCHSN2018-03-21
B095402124Hintermann Series H2Dt Medtech, LLCHSN2018-03-21
B095402125Hintermann Series H2Dt Medtech, LLCHSN2018-03-21
B095322305Hintermann Series H2Dt Medtech, LLCHSN2018-03-20
B095322306Hintermann Series H2Dt Medtech, LLCHSN2018-03-20
B095322307Hintermann Series H2Dt Medtech, LLCHSN2018-03-20
B095322316Hintermann Series H2Dt Medtech, LLCHSN2018-03-20
B095322317Hintermann Series H2Dt Medtech, LLCHSN2018-03-20
B095322325Hintermann Series H2Dt Medtech, LLCHSN2018-03-20
B095322326Hintermann Series H2Dt Medtech, LLCHSN2018-03-20