Model: LPS-APSLL-18
Catalog: LPS-APSLL-18
DI: 00193082168062
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-20
Current Version: 2026-05-28
Description
ANTERIS Plate Assembly, Large, Sacral, 18mm
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:
612d1af0-98e2-4e78-af9f-0aa790c42fd8
Distribution Status:
In Commercial Distribution
DUNS Number:
783908713
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:
Yes
Identifiers
Device ID:
00193082168062
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 46653
Name: Spinal fixation plate, non-bioabsorbable
Definition:
A small, implantable, non-customized sheet of solid material intended to be attached to the spine with screws for spinal immobilization as part of treatment of a spinal instability or deformity; it is made of a material that is not chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). Disposable instruments intended to facilitate implantation, or fixation implants (i.e., bone screws), may be packaged with the plate.
FDA Product Codes
KWQ
Appliance, fixation, spinal intervertebral body
Premarket Submissions
Submission Number:
K260015
Supplement Number:
000