Device
20° ANGLED TRIAL - FOUNDATION 3D TLIF - 37mm X 10mm X 14mm, 12°
Manufacturer
Zavation LLC
Zavation LLC
Model: 02T01039
DI: 00197157077808
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-19
Current Version: 2026-05-27
Description
20° ANGLED TRIAL - FOUNDATION 3D TLIF - 37mm X 10mm X 14mm, 12°
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:
6c561d28-d5ac-4619-9836-6db643055122
Distribution Status:
In Commercial Distribution
DUNS Number:
069472800
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:
00197157077808
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 63093
Name: Internal spinal fixation force sensor trial
Definition:
A copy of a final internal spinal fixation force sensor, typically mounted on a handle, designed to be used to determine availability of adequate space for the fixation of the final temporary sensor used during the implantation procedure of an internal spinal fixation system. This is a reusable device intended to be sterilized prior to use.
FDA Product Codes
MAX
Intervertebral Fusion Device With Bone Graft, Lumbar
Premarket Submissions
Submission Number:
K162496
Supplement Number:
000