FDA.reportPublic FDA data

Hintermann Series H2

Primary DI
B0953228041
Brand
Hintermann Series H2
Company
Dt Medtech, LLC
Model
1
Catalog number
322804
Device description
H2 TIBIAL TRAY SIZE 4 LEFT (7MM)
Published
2020-01-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
B0953228041PrimaryHIBCC0

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
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B095319692Hintermann Series3196923196922026-08-21
B095319865Hintermann Series3198653198652026-08-21
B095319866Hintermann Series3198663198662026-08-21
B095319867Hintermann Series3198673198672026-08-21
B095329646Hintermann Series3296463296462026-08-21
B095399900Hintermann Series3999003999002026-08-21
B095129681Hintermann Series1296811296812018-10-16
B095129682Hintermann Series1296821296822018-10-16
B095129696Hintermann Series1296961296962018-10-16
B095319375Hintermann Series3193753193752018-10-08
B095129680Hintermann Series1296801296802018-10-16
B095129683Hintermann Series1296831296832018-10-16
B095129684Hintermann Series1296841296842018-10-16
B095129685Hintermann Series1296851296852018-10-16
B095129686Hintermann Series1296861296862018-10-16
B095129690Hintermann Series1296901296902018-10-16
B095129691Hintermann Series1296911296912018-10-16
B095129692Hintermann Series1296921296922018-10-16
B095129693Hintermann Series1296931296932018-10-16
B095129694Hintermann Series1296941296942018-10-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00889795150080APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795150097APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795150103APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795150110APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795150127APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795150134APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795151001APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795151018APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795151025APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795151032APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795151049APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795151056APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795151063APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795151070APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795151087APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795151094APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795151100APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795151117APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795151124APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795151131APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795151148APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795151155APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795151162APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795151179APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795151186APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795151193APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795151209APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795151216APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795151223APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795151230APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12