AccessGUDID - DEVICE: VerteGlide Spinal Growth Guidance System (00840194480048)

GUDID

Device Identifier (DI) Information

Brand Name: VerteGlide Spinal Growth Guidance System
Version or Model: 01-1724-1000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 01-1724-1000
Company Name: ORTHOPEDIATRICS CORP.

Primary DI Number: 00840194480048
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 796416191 *Terms of Use

Device Description: 5.5 CLOSED VERTEGLIDE PEDICLE SCREW DRIVER

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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:	Yes
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?
33968	Surgical screwdriver, reusable	A non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OLO	Orthopedic stereotaxic instrument

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K241816	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

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: 5a3c1f41-8800-483b-9d90-294d1d417d0c
Public Version Date: April 08, 2025
Public Version Number: 1
DI Record Publish Date: March 31, 2025