Model: I64-15-08
DI: 00889929072738
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-01
Current Version: 2026-05-11
Description
HELIXX SI Inserter
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:
e44cc224-7682-477e-83bb-f83c932c957a
Distribution Status:
In Commercial Distribution
DUNS Number:
003489810
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
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:
No
Identifiers
Device ID:
00889929072738
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 58849
Name: Sacroiliac joint transarticular fixation/arthrodesis implantation kit
Definition:
A collection of surgical instruments and devices intended to be used for the implantation of a sacroiliac joint transarticular fixation/arthrodesis implant during a minimally-invasive procedure. It typically consists of a tray, dedicated soft-tissue protectors, depth gauges, pin sleeves, drill sleeves, drill bits, broaches, a parallel pin guide, handles, slide hammer shafts, impactors, and a removal/adaptor tool; the implant(s) is not included. This is a reusable device.
FDA Product Codes
OUR
Sacroiliac Joint Fixation
HWC
Screw, Fixation, Bone
Premarket Submissions
Submission Number:
K243838
Supplement Number:
000