Hintermann Series H2

Primary DI
B095401113
Brand
Hintermann Series H2
Company
Dt Medtech, LLC
Model
1
Catalog number
401113
Device description
H2 TALAR COMPONENT RIGHT - SIZE 3
Published
2018-03-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171004000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171004000Hintermann Series H2 Total Ankle SystemDt Medtech, LLC2017-11-07HSN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B095401113PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Coated ankle talus prosthesisA sterile implantable device designed to replace the proximal talus (talar component) as part of a primary ankle joint replacement or prosthesis revision. The device is made of metal [e.g., titanium (Ti), cobalt-chrome (Co-Cr), stainless steel] and is coated with a material (e.g., porous materials, hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth. Fixation devices for implantation (e.g., screws) may be included and implantation may be performed with or without bone cement.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
410-427-0003quality@dtmedtech.com
999-999-9999quality@dtmedtech.com

Regulatory Flags#

DUNS number
080101891
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B095319661Hintermann Series 13196612021-01-16
B095319379Hintermann Series 13193792018-10-01
B095319751Hintermann Series 13197512018-10-01
B095301201Hintermann Series H33012013012012024-02-20
B095301202Hintermann Series H33012023012022024-02-20
B095301203Hintermann Series H33012033012032024-02-20
B095301204Hintermann Series H33012043012042024-02-20
B095301205Hintermann Series H33012053012052024-02-20
B095301206Hintermann Series H33012063012062024-02-20
B095119693Hintermann Series 11296832018-10-16
B095319380Hintermann Series 13193802018-10-17
B095319665Hintermann Series 13196652018-10-15
B095319666Hintermann Series 13196662018-10-15
B095319667Hintermann Series 13196672018-10-15
B095319765Hintermann Series 13197652018-10-17
B095399901Hintermann Series 13999012018-10-16
B095300105Hintermann Series H313001052019-08-19
B095300106Hintermann Series H313001062019-08-19
B095300107Hintermann Series H313001072019-08-19
B095300109Hintermann Series H313001092019-08-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10381780237730Cadence™Ascension Orthopedics, Inc.HSN2016-01-12
10381780237747Cadence™Ascension Orthopedics, Inc.HSN2016-01-12
10381780237754Cadence™Ascension Orthopedics, Inc.HSN2016-01-12
10381780237761Cadence™Ascension Orthopedics, Inc.HSN2016-01-12
10381780237778Cadence™Ascension Orthopedics, Inc.HSN2016-01-12
10381780237785Cadence™Ascension Orthopedics, Inc.HSN2016-01-12
10381780237792Cadence™Ascension Orthopedics, Inc.HSN2016-01-12
10381780237808Cadence™Ascension Orthopedics, Inc.HSN2016-01-12
10381780237815Cadence™Ascension Orthopedics, Inc.HSN2016-01-12
10381780237822Cadence™Ascension Orthopedics, Inc.HSN2016-01-12
10381780237839Cadence™Ascension Orthopedics, Inc.HSN2016-01-12
10381780237846Cadence™Ascension Orthopedics, Inc.HSN2016-01-12
10381780237853Cadence™Ascension Orthopedics, Inc.HSN2016-01-12
10381780237860Cadence™Ascension Orthopedics, Inc.HSN2016-01-12
10381780237877Cadence™Ascension Orthopedics, Inc.HSN2016-01-12
10381780237884Cadence™Ascension Orthopedics, Inc.HSN2016-01-12
10381780237891Cadence™Ascension Orthopedics, Inc.HSN2016-01-12
10381780237907Cadence™Ascension Orthopedics, Inc.HSN2016-01-12
10381780237914Cadence™Ascension Orthopedics, Inc.HSN2016-01-12
10381780237921Cadence™Ascension Orthopedics, Inc.HSN2016-01-12
10381780237938Cadence™Ascension Orthopedics, Inc.HSN2016-01-12
10381780237945Cadence™Ascension Orthopedics, Inc.HSN2016-01-12
10381780237952Cadence™Ascension Orthopedics, Inc.HSN2016-01-12
10381780237969Cadence™Ascension Orthopedics, Inc.HSN2016-01-12
10381780237976Cadence™Ascension Orthopedics, Inc.HSN2016-01-12
10381780237983Cadence™Ascension Orthopedics, Inc.HSN2016-01-12
10381780237990Cadence™Ascension Orthopedics, Inc.HSN2016-01-12
10381780238003Cadence™Ascension Orthopedics, Inc.HSN2016-01-12
10381780238010Cadence™Ascension Orthopedics, Inc.HSN2016-01-12
10381780238027Cadence™Ascension Orthopedics, Inc.HSN2016-01-12