AccessGUDID - DEVICE: HiJAK™ Cervical (M68120190100000)

GUDID

Device Identifier (DI) Information

Brand Name: HiJAK™ Cervical
Version or Model: 2019-01-0000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2019-01-0000
Company Name: ATLAS SPINE, INC.

Primary DI Number: M68120190100000
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 140801007 *Terms of Use

Device Description: Funnel Cup, HiJAK ™ Cervical

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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:	No
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?
47872	Bone graft funnel	A device designed to deliver bone graft filling material (autologous, allogeneic, xenogeneic, or synthetic) during an orthopaedic procedure to enable the filling of bone gaps intended to be fused. It is a funnel-shaped device; the funnel being bowl-shaped with the ability to hold back the filling material depending upon the angle of tilt applied by the surgeon, and a long, thin tube that can be inserted into the site to be filled, e.g., a cancellous bone graft being discharged into the posterior disc space of a vertebra. An orthopaedic graft inserter can be pushed down the funnel tube to press the graft material into the site. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ODP	Intervertebral Fusion Device With Bone Graft, Cervical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K180675	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: b2eef624-44ac-4036-a45c-3fdb2ea38218
Public Version Date: September 07, 2020
Public Version Number: 2
DI Record Publish Date: September 30, 2019