AccessGUDID - DEVICE: OpenLoc-L Spinal Fixation System (08806344361942)

GUDID

Device Identifier (DI) Information

Brand Name: OpenLoc-L Spinal Fixation System
Version or Model: 1901-6320
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1901-6320
Company Name: L&K BIOMED CO. ,LTD.

Primary DI Number: 08806344361942
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 631159324 *Terms of Use

Device Description: Lateral Open Connector Normal Anodized (L1: 34, L2: 20)

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):	No
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?
65114	Bone-screw internal spinal fixation system connector	An implantable, small connecting component of a bone-screw internal spinal fixation system typically in the form of a thin band or small rod with a groove or hole at one or both ends, into which the screw heads and/or primary rods fit, intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, and also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. It is designed as a transverse or longitudinal connecting element to be attached to the corresponding screw heads and/or primary rods; it may also have adjustable length and/or angle and/or allow a small amount of screw/rod movement.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
NKB	Thoracolumbosacral Pedicle Screw System
KWQ	Appliance, Fixation, Spinal Intervertebral Body
KWP	Appliance, Fixation, Spinal Interlaminal

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: 498f2c66-e05a-4738-85b2-ca49b46f3883
Public Version Date: September 11, 2024
Public Version Number: 4
DI Record Publish Date: September 19, 2017