Model: 9736551
DI: 00199150006427
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-04-24
Current Version: 2026-05-04
Description
SW 1.0.1 AXIS CLINICAL APP 9736551
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
3ed2cd01-3df9-41c9-a24b-68e439d50dc8
Distribution Status:
In Commercial Distribution
DUNS Number:
835233107
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:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00199150006427
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 45199
Name: Multi-purpose stereotactic surgery system
Definition:
An electrically-powered assembly of devices that typically consists of a rigid frame, positioning and alignment components, workstation, and a calibrated guide mechanism for precisely positioning probes, other instruments, or implantable devices during a surgical procedure of more than one discipline [e.g., orthopaedic and ear/nose/throat (ENT)]. The system may include computerized functions to store diagnostic images used for image-guided surgery.
FDA Product Codes
HAW
Neurological stereotaxic Instrument
OLO
Orthopedic stereotaxic instrument
PGW
Ear, Nose, and Throat Stereotaxic Instrument
Premarket Submissions
Item #1 - Submission Number:
K253379
Item #1 - Supplement Number:
000
Item #2 - Submission Number:
K253381
Item #2 - Supplement Number:
000
Item #3 - Submission Number:
K253395
Item #3 - Supplement Number:
000