AccessGUDID - DEVICE: CosmoLock Pedicle Screw System (B07311LCL00000)

GUDID

Device Identifier (DI) Information

Brand Name: CosmoLock Pedicle Screw System
Version or Model: 11-LCL-0000
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Kalitec Direct LLC

Primary DI Number: B07311LCL00000
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 041956211 *Terms of Use

Device Description: Locking Cap

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, threaded, implantable, non-bioabsorbable disc intended to be threaded into the 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
MNH	Orthosis, Spondylolisthesis Spinal Fixation
MNI	Orthosis, Spinal Pedicle Fixation

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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: 53651943-4872-4097-af0f-736cc3dcc1c7
Public Version Date: September 11, 2024
Public Version Number: 4
DI Record Publish Date: October 26, 2015