Device
JOINT CALCANEAL (HINTERMANN) DISTRACTOR 6" ACCEPTS 1.6/2.5MM WIRES/PINS
Manufacturer
ORTHO-MED, INC.
ORTHO-MED, INC.
Model: OM 90-4210-SS
Catalog: OM 90-4210-SS
DI: B803904210SS0
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-05-08
Current Version: 2026-05-18
Description
JOINT CALCANEAL (HINTERMANN) DISTRACTOR 6" ACCEPTS 1.6/2.5MM WIRES/PINS
Sterilization
Method Types - Sterilization Method:
Moist Heat or Steam Sterilization
Device Sterile:
No
Sterilization Prior To Use:
Yes
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
c03260e2-50e1-493b-88ca-3a746a0aadc9
Distribution Status:
In Commercial Distribution
DUNS Number:
086618626
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
B803904210SS0
Type:
Primary
Issuing Agency:
HIBCC
GMDN
Code: 62787
Name: Orthopaedic surgical distractor, external
Definition:
A hand-operated surgical instrument designed to noninvasively distract (force apart) a joint to facilitate an orthopaedic surgical procedure (e.g., hip arthroscopy). It is a mechanical tool with a manual trigger, for distraction and release, intended to be stabilized against a fixation point adjacent to the target joint (e.g., between the knee and the thigh for knee distraction, or between the joint and a patient positioner attached to the operating table). This is a reusable device.
FDA Product Codes
GAD
Retractor