Model: 436125450
DI: 00763000858070
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-04-30
Current Version: 2026-05-08
Description
ENDCAP 436125450 EXTENDED 25 X 45MM STER
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:
04ce466e-4c79-49f9-b00e-3c334b0982a4
Distribution Status:
In Commercial Distribution
DUNS Number:
830350380
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:
00763000858070
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 34170
Name: Vertebral body prosthesis
Definition:
An implantable device designed to replace one or more vertebral body(s) that has collapsed or been surgically removed due to trauma, tumour or degenerative disease. Also known as a corpectomy or vertebrectomy spacer, it is in the form of a one-piece or modular hollow cylinder made of inorganic materials (e.g., metal, polymer). It is typically used with supplemental spinal fixation and/or bone graft, and some types are adjustable for in situ adjustment of prosthesis height to allow intraoperative distraction of adjacent vertebrae.
FDA Product Codes
MQP
Spinal vertebral body replacement device
PLR
Spinal vertebral body replacement device - Cervical
Premarket Submissions
Submission Number:
K183510
Supplement Number:
000