FDA.reportPublic FDA data

Hintermann Series

Primary DI
B095319379
Brand
Hintermann Series
Company
Dt Medtech, LLC
Model
1
Catalog number
319379
Device description
Hintermann Series H2 Tibial Impactor
Published
2018-10-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWAImpactor
HXLMallet

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWAImpactorOrthopedic1
HXLMalletGeneral, Plastic Surgery1

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
B095319379PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant impactorA metal and/or plastic hand-held manual surgical instrument designed to position an implant into the body. Its mode of application is by transmission of an impact force to drive the implant into its final position in the body. The proximal end is a handle usually designed to absorb the impact from a surgical hammer or mallet. The distal end is usually shaped to conform to the implant shape, which could be flat or anatomically curved, or shaped like a chisel handle to facilitate the positioning. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
410-427-0003quality@dtmedtech.com
999-999-9999quality@dtmedtech.com
800-521-5002quality@dtmedtech.com

Regulatory Flags#

DUNS number
080101891
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B095319661Hintermann Series 13196612021-01-16
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
B095300209Hintermann Series H313002092019-08-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00885556925690NASmith & Nephew, Inc.HWA2026-06-04
10603295543718ATTUNEDEPUY (IRELAND)HWA2025-10-31
10603295543725ATTUNEDEPUY (IRELAND)HWA2025-10-31
10653160996415Centurion Medical Products CorpMEDLINE INDUSTRIES, INC.HXL2024-07-29
00841732162709GENERIC Surgical InstrumentsCTL Medical CorporationHWA2023-09-27
00841732162716GENERIC Surgical InstrumentsCTL Medical CorporationHWA2023-09-27
00841732162754GENERIC Surgical InstrumentsCTL Medical CorporationHXL2023-09-27
07613327538601INSTRUMENTHowmedica Osteonics Corp.HWA2023-06-30
10603295549581INHANCEDEPUY (IRELAND)HWA2023-02-28
10603295539346INHANCEDEPUY (IRELAND)HWA2021-08-30
10381780503958Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHXL2020-10-01
07640178983052JULIET ® INSTRUMENTATIONSpineArt SAHWA2019-02-01
10705034717364NASynthes GmbHHWA2019-01-18
10381780509073Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHXL2018-10-23
10603295423324ATTUNEDEPUY (IRELAND)HWA2018-09-24
M684201620111MICROPORTMicroport Orthopedics Inc.HWA2018-09-13
10381780507796Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHXL2018-09-12
10381780508014Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHXL2018-09-12
10381780508083Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHXL2018-09-12
10381780508090Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHXL2018-09-12
10705034720883NASYNTHES (U.S.A.) LPHWA2018-08-17
10381780408451Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHWA2018-08-16
10381780479406Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHWA2018-08-16
10381780184942Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHXL2018-05-02
10381780184959Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHXL2018-05-02
10381780266389Integra™Allograft Wedge SystemAscension Orthopedics, Inc.HWA2018-04-13
10381780282457Integra® PyroCarbonAscension Orthopedics, Inc.HWA2018-04-13
10381780279495K2™ Hemi Toe Implant SystemAscension Orthopedics, Inc.HWA2018-04-10
10381780279907KGTI™ Kinetik Great Toe Implant SystemAscension Orthopedics, Inc.HWA2018-04-10
10381780460701Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHXL2018-04-03