AccessGUDID - DEVICE: CastleLoc-S Posterior Cervical Fixation System/LnK Posterior Cervical Fixation S (08806344345744)

GUDID

Device Identifier (DI) Information

Brand Name: CastleLoc-S Posterior Cervical Fixation System/LnK Posterior Cervical Fixation S
Version or Model: 6118-3538
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 6118-3538
Company Name: L&K BIOMED CO. ,LTD.

Primary DI Number: 08806344345744
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 631159324 *Terms of Use

Device Description: Cervical Partially Semi Reduction Axial Screw Ø3.5, 38mm

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?
46651	Spinal bone screw, non-bioabsorbable	A small, threaded, implantable rod with a slotted head intended to be used for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is available in various types, including pedicle and transfacet, and is typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
KWP	Appliance, Fixation, Spinal Interlaminal
NKG	Orthosis, Cervical Pedicle Screw Spinal 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: 304edd25-34bf-42a7-a853-7447e7794a81
Public Version Date: June 04, 2024
Public Version Number: 3
DI Record Publish Date: July 07, 2017