AccessGUDID - DEVICE: RENOIR Posterior Cervico-Thoracic Fixation System (00841732104440)

GUDID

Device Identifier (DI) Information

Brand Name: RENOIR Posterior Cervico-Thoracic Fixation System
Version or Model: 012.1405
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: CTL Medical Corporation

Primary DI Number: 00841732104440
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080138504 *Terms of Use

Device Description: Set Screw, Cap Head, Star, OD7 x L3.5mm

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?
65553	Spinal bone set screw	A small, implantable, non-bioabsorbable disc, threaded on its outside surface, intended to be threaded into the internal proximal end of a spinal bone screw head/rod adaptor, anchor, connector and/or hook (none included) to secure/stabilize a rod and/or tether as part of an internal spinal fixation procedure or a treatment for idiopathic scoliosis. It is made of metal (e.g., surgical steel, titanium alloy).	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MNI	ORTHOSIS, SPINAL PEDICLE FIXATION

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K121136	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
Device Size Text, specify: OD7
Length: 3.5 Millimeter

Device Record Status

Public Device Record Key: e63b3759-31d8-48f8-941d-e6d70cc7d833
Public Version Date: July 14, 2025
Public Version Number: 7
DI Record Publish Date: March 05, 2016