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LINK™ External Fixator

FDA UDI

Class II (US FDA UDI)

by Metric Medical Devices, Inc.

Identity

Trade Name
LINK™ External Fixator FDA UDI
Generic Name
External orthopaedic fixation system, single-use FDA UDI
Device Name
1.6 mm Diameter, Threaded Bone Pins as part of the LINK™ External Fixator, provided in a segregate package to allow for control of the amount of pins used per procedure. The LINK™ External Fixator is indicated for use in the treatment of bone conditions including osteotomy, arthrodesis, fracture fixation and other bone conditions amenable to treatment by use of the external fixation modality. The LINK™ External Fixation System components are not intended to replace normal healthy bone or to withstand the stresses of full weightbearing, particularly in unstable fractures or in the presence of non-union, delayed union or incomplete healing. The use of external supports (e.g. walking aids) is recommended as a part of the treatment. FDA UDI
Model / Reference
16TT FDA UDI
Description
1.6 mm Diameter, Threaded Bone Pins as part of the LINK™ External Fixator, provided in a segregate package to allow for control of the amount of pins used per procedure. The LINK™ External Fixator is indicated for use in the treatment of bone conditions including osteotomy, arthrodesis, fracture fixation and other bone conditions amenable to treatment by use of the external fixation modality. The LINK™ External Fixation System components are not intended to replace normal healthy bone or to withstand the stresses of full weightbearing, particularly in unstable fractures or in the presence of non-union, delayed union or incomplete healing. The use of external supports (e.g. walking aids) is recommended as a part of the treatment. FDA UDI

Identifiers

Catalog Number
16TT FDA UDI
Primary DI / UDI-DI
M96316TT0 FDA UDI
510(k) Number
K240049 FDA UDI
FDA Product Code
KTT FDA UDI
GMDN Term
External orthopaedic fixation system, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3030 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

Yes

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 Unsafe FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 1.6 Millimeter FDA UDI
Length — 6 Inch FDA UDI

Category: External orthopaedic fixation system, single-use

LINK™ External Fixator by Metric Medical Devices, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as External orthopaedic fixation system, single-use.

Cleared under the same submission

K240049 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Metric Medical Devices, Inc.

Sources (1)

  • FDA UDI a3254a58-ce76-4af6-ad2d-fe4fe710f648 37 fields · synced May 30, 2026