Device
Special, AltiVate Reverse Small Insert Trial, 48mm, Semi
Manufacturer
Encore Medical, L.P.
Encore Medical, L.P.
Model: S-201970
DI: 00190446978268
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-05-01
Current Version: 2026-05-11
Description
Special, AltiVate Reverse Small Insert Trial, 48mm, Semi
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:
178799fa-2a44-4696-80bf-fb5093fa3a22
Distribution Status:
In Commercial Distribution
DUNS Number:
154074504
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:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
Yes
Identifiers
Device ID:
00190446978268
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