FDA.reportPublic FDA data

Hintermann Series H3

Primary DI
B095301201
Brand
Hintermann Series H3
Company
Dt Medtech, LLC
Model
301201
Catalog number
301201
Device description
H3 TIBIAL COMPONENT RIGHT SIZE 1
Published
2024-02-20
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
NTGProsthesis, Ankle, Uncemented, Non-Constrained

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NTGProsthesis, Ankle, Uncemented, Non-ConstrainedUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P160036000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P160036000Hintermann Series H3 Total Ankle Replacement SystemDt Medtech, LLC2019-06-04NTG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B095301201PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Coated ankle tibia prosthesisA sterile implantable device designed to replace the distal tibia (tibial 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
999-999-9999quality@dtmedtech.com
800-521-5002quality@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
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
B095300209Hintermann Series H313002092019-08-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850062461949Tibial Impactor Tips Trilliant Surgical, LLCNTG2024-08-09
008100283934796mm STAR E+ Sliding Core STAR Total AnkleTrilliant Surgical, LLCNTG2024-08-06
008100283934867mm STAR E+ Sliding Core STAR Total AnkleTrilliant Surgical, LLCNTG2024-08-06
008100283934938mm STAR E+ Sliding Core STAR Total AnkleTrilliant Surgical, LLCNTG2024-08-06
008100283935099mm STAR E+ Sliding Core STAR Total AnkleTrilliant Surgical, LLCNTG2024-08-06
0081002839351610mm STAR E+ Sliding Core STAR Total AnkleTrilliant Surgical, LLCNTG2024-08-06
0081002839352311mm STAR E+ Sliding Core STAR Total AnkleTrilliant Surgical, LLCNTG2024-08-06
0081002839353012mm STAR E+ Sliding Core STAR Total AnkleTrilliant Surgical, LLCNTG2024-08-06
0081002839354713mm STAR E+ Sliding Core STAR Total AnkleTrilliant Surgical, LLCNTG2024-08-06
0081002839355414mm STAR E+ Sliding Core STAR Total AnkleTrilliant Surgical, LLCNTG2024-08-06
0085006246136914mm E+ Slide Core STAR ImplantTrilliant Surgical, LLCNTG2024-08-06
B095301202Hintermann Series H3Dt Medtech, LLCNTG2024-02-20
B095301203Hintermann Series H3Dt Medtech, LLCNTG2024-02-20
B095301204Hintermann Series H3Dt Medtech, LLCNTG2024-02-20
B095301205Hintermann Series H3Dt Medtech, LLCNTG2024-02-20
B095301206Hintermann Series H3Dt Medtech, LLCNTG2024-02-20
00810028393431STAR PSI Tibia Cut GuideTrilliant Surgical, LLCNTG2022-11-30
00810028393448STAR PSI Tibia Anatomical ModelTrilliant Surgical, LLCNTG2022-11-30
00810028393455STAR PSI Talus Cut GuideTrilliant Surgical, LLCNTG2022-11-30
00810028393462STAR PSI Talus Anatomical ModelTrilliant Surgical, LLCNTG2022-11-30
00810028394971STAR PSI Standard Bundle with Anatomical ModelsTrilliant Surgical, LLCNTG2022-11-30
00886385017365STARStryker GmbHNTG2022-02-14
00886385018836STARStryker GmbHNTG2022-02-14
00886385018843STARStryker GmbHNTG2022-02-14
00886385019055STARStryker GmbHNTG2022-02-14
00886385019062STARStryker GmbHNTG2022-02-14
00886385019147STARStryker GmbHNTG2022-02-14
B095302113Hintermann Series H3Dt Medtech, LLCNTG2019-08-20
B095302125Hintermann Series H3Dt Medtech, LLCNTG2019-08-20
B095300506Hintermann Series H3Dt Medtech, LLCNTG2019-08-20