Model: FURS-4101
DI: 00817337000364
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-21
Current Version: 2026-05-29
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
5fbc5b49-6fa4-4108-a87f-7e8ed042e2e0
Distribution Status:
In Commercial Distribution
DUNS Number:
807613393
Device Count:
5
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:
Yes
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Item #1 - Device ID:
00817337000364
Item #1 - Device ID Type:
Primary
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
00817337000357
Item #2 - Device ID Type:
Unit of Use
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 61411
Name: Subchondral bone needling device
Definition:
A sterile, metallic surgical instrument intended to be used to create thin channels in the bone layer beneath articular cartilage to enable migration of bone marrow (blood stem) cells to promote healing of a cartilage defect. Otherwise known as nanofracture, subchondral bone needling uses non-rotational force (hammering) during an arthroscopic procedure. It is made of metal [e.g., nickel-titanium alloy (Nitinol)] in the form of a long thin spike with a bulbous proximal end and is typically used with a reusable handle (not included). This is a single-use device.
FDA Product Codes
LXH
Orthopedic Manual Surgical Instrument