AccessGUDID - DEVICE: Pulsar Expandable PLIF System (08800104089794)

GUDID

Device Identifier (DI) Information

Brand Name: Pulsar Expandable PLIF System
Version or Model: 2212-0810
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2212-0810
Company Name: GS Medical Co., Ltd.

Primary DI Number: 08800104089794
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 688385418 *Terms of Use

Device Description: The Pulsar Expandable PLIF Cage devices are designed for restoring the height of the intervertebral space after resection of the disc. The Pulsar Expandable PLIF Cage devices consist of implants in various heights, footprints, and lordotic configurations with architecture designed to accept pre and post packing of bone graft material. The intervertebral body devices are made of titanium alloy (Ti-6AL-4V ELI). The Pulsar Expandable PLIF Cage devices are not radio lucent, but have large windows through the sides that will allow visualization of the placement and subsequent bone fusion. The Expandable PLIF Cage (Posterior Lumbar Interbody Fusion Cage) are designed for segments L2 to S1.

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?
60762	Polymeric spinal interbody fusion cage	A device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be included with the device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K221687	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: dc1aa9ec-092a-4ba9-8545-94595a8ca37c
Public Version Date: November 02, 2022
Public Version Number: 1
DI Record Publish Date: October 25, 2022