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OsteoBridge™ IDSF Diaphysis Tibial Nail

FDA UDI

Class II (US FDA UDI)

by Merete GmbH

Identity

Trade Name
OsteoBridge™ IDSF Diaphysis Tibial Nail FDA UDI
Generic Name
Diaphysis prosthesis FDA UDI
Model / Reference
9 90 FDA UDI

Identifiers

Catalog Number
GB40909S FDA UDI
Primary DI / UDI-DI
04048266166647 FDA UDI
510(k) Number
K181026 FDA UDI
FDA Product Code
HSB FDA UDI
GMDN Term
Diaphysis prosthesis FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3020 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

Dimensions & Sizes

Size
Outer Diameter — 9 Millimeter FDA UDI
Length — 90 Millimeter FDA UDI

Category: Diaphysis prosthesis

OsteoBridge™ IDSF Diaphysis Tibial Nail by Merete GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Diaphysis prosthesis.

Cleared under the same submission

K181026 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Merete GmbH

Sources (1)

  • FDA UDI 0ec4d426-6f52-43ec-8690-e9804ac65de3 36 fields · synced Jun 1, 2026