Device
Headless Screw, Partially Threaded, Short, 5.5mm, 75mm Length
Manufacturer
Pace Surgical, Inc.
Pace Surgical, Inc.
Model: PS1-2155075
Catalog: PS1-2155075
DI: 00810211042962
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-04-27
Current Version: 2026-05-05
Description
Headless Screw, Partially Threaded, Short, 5.5mm, 75mm Length
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:
e2551d8d-a239-4d11-a297-a53aad9c602b
Distribution Status:
In Commercial Distribution
DUNS Number:
119302878
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:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00810211042962
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 66947
Name: Orthopaedic bone screw (non-sliding)
Definition:
A small, threaded, non-bioabsorbable, implantable rod intended for internal orthopaedic fixation by being screwed into a limb bone, rib, the sternum and/or pelvis to hold a plate, nail, rod or prosthesis to the bone, or to provide direct interfragmentary stabilization of a fractured bone; it is not intended to be introduced through the sleeve of a femoral neck fixation plate/sleeve, not used in dentistry/orthodontics, craniofacial or spinal bones, and not dedicated to intramedullary fixation/arthrodesis. It is typically of cortical or cancellous design and has a drive (e.g., slot, cross, star, polygonal) at its proximal end for introduction with a screwdriver.
FDA Product Codes
HWC
Screw, Fixation, Bone
Premarket Submissions
Submission Number:
K251555
Supplement Number:
000