Device
K-WIRE D.TROCAR PT. 4” .062” (1.6mm)
Manufacturer
Apex (Guangzhou) Tools & Orthopedics Co.
Apex (Guangzhou) Tools & Orthopedics Co.
Model: KQ-16104NT
Catalog: KQ-16104NT
DI: 06957277203204
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-15
Current Version: 2026-05-25
Description
K-WIRE D.TROCAR PT. 4” .062” (1.6mm)
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:
a45ccc79-0ce5-46bd-9303-80732bbcbf6b
Distribution Status:
In Commercial Distribution
DUNS Number:
529936792
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:
06957277203204
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 32854
Name: Orthopaedic bone pin, non-bioabsorbable
Definition:
A thin, implantable rod intended to be used for the stabilization of a bone fracture or bone grafts, or for an osteotomy or arthrodesis (internal and/or external fixation). It is typically drilled into bone and may be smooth or threaded, solid or cannulated, and/or semi-flexible. Also known as a Kirschner-wire (K-wire), it may in addition be intended to assist with the introduction of a surgical instrument and/or implant; it is not intended for implantation into the intramedullary canal (i.e., not a nail). It is made of a non-bioabsorbable material (e.g., stainless steel). Some designs may have a break-off shank and/or be coated to improve long-term fixation. This is a single-use device.
FDA Product Codes
HTY
Pin, Fixation, Smooth
Premarket Submissions
Submission Number:
K121004
Supplement Number:
000