FDA.reportPublic FDA data

Hintermann Series

Primary DI
B095319309
Brand
Hintermann Series
Company
Dt Medtech, LLC
Model
1
Catalog number
319309
Device description
Talar peg dril l4.5mm Instrument
Published
2018-10-04
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
HTZInstrument, Cutting, Orthopedic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTZInstrument, Cutting, OrthopedicGeneral, 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
B095319309PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical drill guide, reusableA manual surgical device designed to simultaneously place, angle, and guide a rotating surgical drill on hard tissue (e.g., bone); some types are also intended for guiding bone-coring instruments (e.g., keel punch). It is designed in a tubular form or with guiding holes and may have serrations at its distal end to enable firm placement on hard tissue surfaces (it is not bored into the tissue); it can have a handle or be held by another device (e.g., orthopaedic jig), and typically allows protection of the surrounding soft tissue during surgery. It is typically made of metal and may have graduations along its length; it is not custom-made for a specific patient. 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

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
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
10603295552390ATTUNEDEPUY ORTHOPAEDICS, INC.HTZ2026-05-18
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00196449034185Anatomic Access LLIFTyber Medical, LLCHTZ2025-10-22
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00196449034208Anatomic Access LLIFTyber Medical, LLCHTZ2025-10-22
00196449034673Anatomic Access LLIFTyber Medical, LLCHTZ2025-10-22
00196449034680Anatomic Access LLIFTyber Medical, LLCHTZ2025-10-22
00196449034697Anatomic Access LLIFTyber Medical, LLCHTZ2025-10-22
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B471293000150GEO-DesisGRAMERCY EXTREMITY ORTHOPEDICS LLCHTZ2025-01-17
B471293000200GEO-DesisGRAMERCY EXTREMITY ORTHOPEDICS LLCHTZ2025-01-17
B471293000250GEO-DesisGRAMERCY EXTREMITY ORTHOPEDICS LLCHTZ2025-01-17
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