Model: TP.IN.0014
Catalog: CPN-00001
DI: 00840354205207
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: No
First Published: 2026-05-07
Current Version: 2026-05-15
Description
Disposable Pre-fixation Pin
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:
0df87cfd-06cb-4d07-973c-64c4066d35cc
Distribution Status:
In Commercial Distribution
DUNS Number:
094374525
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
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:
00840354205207
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 66937
Name: Spinal intraoperative positioning/manipulation pin, single-use
Definition:
A nonimplantable rod with an external cylindrical and/or polygonal drive intended to be temporarily introduced, with a dedicated tool (not included), into vertebral bone to: 1) assist with positioning of an implantable device; and/or 2) interface with a surgical instrument (e.g., fixation plate, distractor/retractor) during spinal surgery. It may be threaded; however, as a pin it is designed such that a significant length protrudes from vertebral bone once introduced (i.e., not a positioning screw). This is a single-use device.
FDA Product Codes
KWQ
Appliance, Fixation, Spinal Intervertebral Body