AccessGUDID - DEVICE: SureLOK Mini Posterior Cervical/Upper Thoracic System (00840019907651)

GUDID

Device Identifier (DI) Information

Brand Name: SureLOK Mini Posterior Cervical/Upper Thoracic System
Version or Model: 04-1017-30
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 04-1017-30
Company Name: PRECISION SPINE, INC.

Primary DI Number: 00840019907651
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079398589 *Terms of Use

Device Description: 30mm Cervical Crosslink

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?
65114	Bone-screw internal spinal fixation system connector	An implantable 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 each end, into which screw heads/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)]. This component is designed as a transverse connecting element to be attached to corresponding bilateral screw heads or 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
KWP	Appliance, Fixation, Spinal Interlaminal

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K150851	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
No Device Sizes

Device Record Status

Public Device Record Key: c40dc5b7-dbc9-4dde-a3ff-c8da23d34aed
Public Version Date: May 17, 2024
Public Version Number: 2
DI Record Publish Date: April 10, 2019