Model: SRI-10050
DI: 00810094692940
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-15
Current Version: 2026-05-25
Description
AP Sizer with Short Legs
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:
d36b7663-7f16-462c-b574-1122750e4916
Distribution Status:
In Commercial Distribution
DUNS Number:
078416717
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
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:
00810094692940
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 13180
Name: Orthopaedic prosthesis implantation positioning instrument, reusable
Definition:
A hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prostheses, or prosthesis components; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) between prosthesis components. This is a reusable device intended to be sterilized prior to use.
FDA Product Codes
LXH
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Environmental Conditions
Storage Handling - Storage Handling Type:
Special Storage Condition, Specify
Storage Handling - Storage Handling Special Condition Text:
The Klassic Knee System should be stored in a clean, dry location at room
temperature