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Hintermann Series H2

FDA UDI

Class II (US FDA UDI)

by Dt Medtech, LLC

Identity

Trade Name
Hintermann Series H2 FDA UDI
Generic Name
Ankle prosthesis bearing FDA UDI
Device Name
H2 PE INLAY SIZE 3 LEFT 6MM/NEUTRAL FDA UDI
Model / Reference
1 FDA UDI
Description
H2 PE INLAY SIZE 3 LEFT 6MM/NEUTRAL FDA UDI

Identifiers

Catalog Number
322306 FDA UDI
Primary DI / UDI-DI
B095322306 FDA UDI
510(k) Number
K171004 FDA UDI
FDA Product Code
HSN FDA UDI
GMDN Term
Ankle prosthesis bearing FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3110 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Ankle prosthesis bearing

Hintermann Series H2 by Dt Medtech, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ankle prosthesis bearing.

Cleared under the same submission

K171004 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Dt Medtech, LLC

Sources (1)

  • FDA UDI 7e9cf770-581b-4391-8852-97e37f5da221 36 fields · synced Jun 1, 2026