FDA.reportPublic FDA data

Hintermann Series H3

Primary DI
B095300506
Brand
Hintermann Series H3
Company
Dt Medtech, LLC
Model
300506
Catalog number
300506
Device description
H3 PE INLAY SIZE 5 - 6mm
Published
2019-08-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
B095300506PrimaryHIBCC0

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.

Device Sizes#

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

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
B095119631Hintermann Series1196311196312018-10-16
B095119632Hintermann Series1196321196322018-10-16
B095159127Hintermann Series1591271591272018-10-16
B095319670Hintermann Series3196703196702018-10-16
B095319671Hintermann Series3196713196712018-10-16
B095319672Hintermann Series3196723196722018-10-16
B095319792Hintermann Series3197923197922018-10-16
B095319793Hintermann Series3197933197932018-10-16
B095319799Hintermann Series3197993197992018-10-16
B095322129Hintermann Series H23221293221292018-03-19
B095322215Hintermann Series H23222153222152018-03-19
B095322217Hintermann Series H23222173222172018-03-19
B095322219Hintermann Series H23222193222192018-03-19
B095322226Hintermann Series H23222263222262018-03-19
B095322305Hintermann Series H23223053223052018-03-20
B095322306Hintermann Series H23223063223062018-03-20
B095322307Hintermann Series H23223073223072018-03-20
B095322315Hintermann Series H23223153223152018-03-20
B095322316Hintermann Series H23223163223162018-03-20
B095322317Hintermann Series H23223173223172018-03-20

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
B095301201Hintermann Series H3Dt Medtech, LLCNTG2024-02-20
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