AccessGUDID - DEVICE: LINK™ External Fixator (M9634H201020)

GUDID

Device Identifier (DI) Information

Brand Name: LINK™ External Fixator
Version or Model: 4H201020
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 4H201020
Company Name: METRIC MEDICAL DEVICES, INC.

Primary DI Number: M9634H201020
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 830255506 *Terms of Use

Device Description: LINK™ External Fixator, 4 Pin, Square Configuration intended for assembly and use with appropriately sized Bone Pins designed to stabilize fractured bones, osteotomies or arthrodesis to promote treatment and healing. This is a single-use device that is provided sterile. A Silicone cover is provided within the package to assist with the protection of the LINK™ structure. 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.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
48011	External orthopaedic fixation system, single-use	An assembly of devices designed to stabilize fractured bones to promote treatment and healing. It typically consists of an external plastic and/or metallic fixator (a framework) and other external and/or implantable components such as clamps, rods, rings, pins, bolts, and nuts, as well as some reusable instrumentation (e.g., wrenches, depth gauge, tensioner). It is used mainly to help the healing of long bones such as the femur, tibia and humerus, as well as fractures of the foot and ankle, joint fusions, and limb lengthening. This is a single-use device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K240049	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: less than 76.7 Degrees Celsius
Storage Environment Temperature: less than 170 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 4 Pin, H configuration, Pin Hole to Pin Hole 20mm in Length, 10mm in width

Device Record Status

Public Device Record Key: 52ff1fe3-5241-4c8c-9e73-41d2491ace16
Public Version Date: June 17, 2024
Public Version Number: 1
DI Record Publish Date: June 07, 2024