AccessGUDID - DEVICE: CD HORIZON® Growth Rod Conversion Set (00643169500525)

GUDID

Device Identifier (DI) Information

Brand Name: CD HORIZON® Growth Rod Conversion Set
Version or Model: 811191GR
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: MEDTRONIC SOFAMOR DANEK, INC.

Primary DI Number: 00643169500525
Issuing Agency: GS1
Commercial Distribution End Date: March 11, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 830350380 *Terms of Use

Device Description: CONNECTOR 811191GR 110MM SS 4.5MM ROD S

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:	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?
61324	Bone-screw internal spinal fixation system, sterile	An assembly of sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Sterile disposable devices associated with implantation may be included.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
PGM	Growing rod system

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K150200	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
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
Device Size Text, specify: DIA= 4.5mm L=110mm

Device Record Status

Public Device Record Key: 8f98c4eb-86aa-4609-b233-70334e96e8e0
Public Version Date: July 02, 2025
Public Version Number: 5
DI Record Publish Date: March 16, 2016