AccessGUDID - DEVICE: SIros-X (M719GSIX1020)

GUDID

Device Identifier (DI) Information

Brand Name: SIros-X
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: GSI-X102
Company Name: Genesys Orthopedics Systems LLC

Primary DI Number: M719GSIX1020
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 017921066 *Terms of Use

Device Description: SIros-X Nav Straight Lenke Probe

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
45169	Stereotactic surgery system probe, reusable	A slender, rod-like, hand-held manual surgical instrument intended for use during image-guided surgery (e.g., neurosurgical or orthopaedic surgery procedures) to accurately position implantable devices (e.g., shunts), or to correlate the position of its tip with that of a targeted tissue of interest in a patient so the tissue area is precisely identified with respect to diagnostic images stored in the stereotactic surgery system. It is made of metal. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OUR	Sacroiliac Joint Fixation
OLO	Orthopedic Stereotaxic Instrument
NKB	Thoracolumbosacral Pedicle Screw System

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K252322	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 82d10e09-7f2d-4680-abe4-75d70cd3e839
Public Version Date: February 03, 2026
Public Version Number: 1
DI Record Publish Date: January 26, 2026

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 5123817070
Email: info@genesysspine.com

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