Device
CR Insert Trial with Handle Mating Hole Size 2 16mm
Manufacturer
Ortho Development Corporation
Ortho Development Corporation
Model: C-1857-16
DI: 00822409133338
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-16
Current Version: 2026-05-25
Description
CR Insert Trial with Handle Mating Hole Size 2 16mm
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:
95c55288-4a80-453f-b165-3e794e0cbcd4
Distribution Status:
In Commercial Distribution
DUNS Number:
876542390
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00822409133338
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 58716
Name: Knee tibia prosthesis trial, reusable
Definition:
A copy of a final tibia prosthesis designed to be used during unicompartmental knee replacement surgery or total knee arthroplasty (TKA) to determine the correct alignment, size, and fit of the final prosthesis. It is one of a set, or a set, of graduated sizes, and may be used in conjunction with a knee femur trial prosthesis and a patella trial prosthesis. It is typically made of metal or polymer material and includes tibial base plate trials, tibial spacer trials, tibial insert trials, tibial stem trials, tibial wedge/augment trials, and guide pin trials. This is a reusable device.
FDA Product Codes
LXH
Orthopedic manual surgical instrument