Device
Cervical Existing Plate Distraction Pin, Bayoneted
Manufacturer
ALPHATEC SPINE, INC.
ALPHATEC SPINE, INC.
Model: CI-11994-02
DI: 00840180546437
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-15
Current Version: 2026-05-25
Description
Cervical Existing Plate Distraction Pin, Bayoneted
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:
ac63174b-7b7f-44dc-b161-6824f69d5324
Distribution Status:
In Commercial Distribution
DUNS Number:
602465783
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
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:
00840180546437
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
LXH
Orthopedic manual surgical instrument